2011 annual meeting abstracts

ABST

RACT

SAmerican College of Clinical Pharmacy

2011 Annual Meeting

Presentation Abstracts andIndex of Authors

www.pharmacotherapyjournal.org

PHARMACOTHERAPY Volume 31, 2011312e

2011 ACCP Annual Meeting

October 16–19, 2011

Pittsburgh, PA(Pharmacotherapy 2011;31(10)311e–453e)

ORIGINAL RESEARCH

ADR/Drug Interactions 1. Comparison of online drug interaction databases to evaluateantiretroviral medication interactions. Tomasz Z. Jodlowski,Pharm.D., BCPS, (AQ-ID)1, Priti N. Patel, Pharm.D., BCPS1, NicoleM. Maisch, Pharm.D.1, Donna Mildvan, M.D.2; (1)St. John’sUniversity College of Pharmacy and Allied Health Professions,Queens, NY; (2)Beth Israel Medical Center, New York, NY PURPOSE: Treatment of the human immunodeficiency virus (HIV)is complex and clinicians often look to drug interaction evaluationtools to assist in daily patient care. Although technology has beenshown to improve patient safety, the use of online drug interactiontools to evaluate antiretroviral interactions has not been evaluated. Thepurpose of this study was to compare online drug interaction databaseswith a focus on antiretroviral medications. METHODS: Twelve online drug interaction databases wereevaluated: Micromedex Thomson Healthcare Series (MM),Universityof Liverpool (UL), Clinical Pharmacology (CP), Clinical Care Options(CCO), AIDSmeds (AM), Medscape Drug Reference (MDR), Lexi-Complete (LC), Johns Hopkins HIV Guide (JHHIVG), Facts andComparisons eAnswers Drug Interaction Interactive Tool (FC),Epocrates online free (EOF), HIV In Site (IS) and Drug InteractionFacts eBook (DIF). The databases were evaluated for scope (databasecorrectly identify the presence of a drug interaction) andcomprehensiveness (depth of information provided for a correctlyidentified drug interaction) using 40 drug pairs. Subsequently thedatabases were ranked based on scope and comprehensiveness scores(Excellent: ≥ 90%, Satisfactory: 89–60%, Poor: < 60%). RESULTS: MM, UL, CP and CCO were considered excellent basedon scope (≥ 90%) and MM, UL, CP, LC, MDR and CCO wereconsidered satisfactory based on comprehensiveness score (89–60%).No database was ranked as excellent in comprehensiveness. There wasno statistically significant difference in scope between free andsubscription databases (p>0.05) or between HIV-specific and generaldatabases (p>0.05). There was a statistically significant difference incomprehensiveness favoring subscription databases (p<0.05), howeverno difference was observed between general and HIV specificsoftware (p>0.05). CONCLUSION: MM, UL, CP, and CCO were the only databases inthe study that achieved highest rank for both scope (excellent) andcomprehensiveness (satisfactory). Clinicians should periodicallyevaluate their preferred database and consider checking multipleresources when evaluating drug interactions.

2. Comparing the type and severity of drug interactions amongdifferent ICUs. Pamela L. Smithburger, Pharm.D., BCPS, Sandra L.Kane-Gill, Pharm.D., MSc, FCCM, FCCP, Amy L. Seybert, Pharm.D.;University of Pittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: Mortality and morbidity are increased in patientsexperiencing drug-drug interactions (DDIs), and there is a lack ofliterature describing clinically significant DDIs in the intensive careunit (ICU). It is also unknown if there are differences in severity andtype of DDIs between different ICUs. Our objective is to identifyDDIs occurring in the medical ICU (MICU), cardiovascular ICU(CCU), and the cardiothoracic ICU (CTICU) and compare the severityand types of medications involved in the DDIs between the units. METHODS: This prospective, observational study was conducted for 4weeks in each of the 3 ICUs (MICU, CCU, CTICU) of an academic

medical center. Patients ≥18 years of age and admitted to the ICU underobservation during the month of study were included. Lexi-Interact™and Micromedex® interaction databases were utilized daily to screeneach patient’s medication profile for interacting drug pairs. Severity ofthe DDI was assessed by each databases’ severity rating scale. RESULTS: Overall, 736 patient medication profiles were evaluatedwith 343 profiles possessing ≥ 1 DDI. There were a total of 1670DDIs identified (2.27 DDI/ patient-day) with 813 being uniqueinteracting drug pairs. DDIs were major or contraindicated in 4.7%(14/296), 8.9% (19/213), and 2.5% (8/355) of the CCU, CTICU, andMICU DDIs, respectively. Upon evaluation of the agreement ofseverity ratings between the interaction databases, more variance wasnoted in the MICU DDIs. Differences also existed between themedications involved in the most common DDIs in the MICUcompared to the other units. CONCLUSION: DDIs occur frequently in the ICU setting, and thetype and severity of DDIs may be influenced by the patientpopulation, co-morbid disease states and reason for admission. Whendeveloping an alerting system for DDIs, patient characteristics andlocation should be taken into consideration to develop an optimalwarning system.

3. Incidence, characteristics, and outcomes of adverse drug eventsresulting in intensive care admission in oncology patients. Lama H.Nazer, Pharm.D., BCPS, Feras I. Hawari, M.D., Rana A. Eljaber,Pharm.D.; King Hussein Cancer Center, Amman, Jordan PURPOSE: to determine the incidence, characteristics, and outcomesof adverse drug events (ADEs) that necessitate admission to theintensive care unit (ICU) in oncology patients. METHODS: This was a 5-month prospective observational studyconducted between August 1st and December 31st, 2010 at acomprehensive academic cancer center. Patients admitted to the ICUwere screened within 48 hours to determine if the admission may havebeen due to a drug related adverse event. An ADE was defined as aninjury or patient harm resulting from medical intervention related to adrug. ADEs were characterized based on the suspected medication,organ system involved, and severity and preventability. Patientdemographics, length of stay, and mortality were recorded. RESULTS: During the study period, 249 patients were screened. Themajority of patients had solid tumors (n=179; 72.2%); the remaininghad hematological malignancies (n=79; 31.7%). Of the patientsadmitted, 134 (53.4%) were males and the average age was 52.1 ±15.8(SD) (range: 19-88) years. An ADE was determined as the primarycause of 58 (23.3%) admissions. The most common medicationsassociated with an ADE requiring an ICU admission wereantineoplastics (n=38; 62.3%) and analgesics (n=9; 14.8%). Othermedications associated with an ADE requiring an ICU admissionwere: anticoagulants, diabetes medications, corticosteroids,immunosuppressants, and contrast agents. The most common types ofadverse events were hematological/immune (n=33; 54.1%),neurologic (n=10; 16.4%), and respiratory (n=7; 11.5%). Five (8.6%)of the ADEs were considered preventable. The average length of stayfor the patients admitted with ADEs resulting in ICU admission was5.95 days ±9.43(SD) and the mortality rate was 27.1%. CONCLUSION: To our knowledge, this is the first study to report onADEs resulting in ICU admission in oncology patients. The incidenceof ADEs in this patient population is high and often life-threateningand fatal.

4E. Evaluating the occurrence of QT prolongation resulting fromdrug-drug interactions. Michael J. Armahizer, Pharm.D.1, SandraKane-Gill, Pharm.D., M.S., FCCM2, Pamela L. Smithburger,Pharm.D., BCPS2, Amy L. Seybert, Pharm.D.2; (1)UPMCPresbyterian, Pittsburgh, PA; (2)University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: Over 50 medications cause QT prolongation, which candeteriorate into Torsades de pointes. Information is lacking on thefrequency of QT prolongation due to drug-drug interactions (DDIs)accounting for temporal sequence in intensive care units (ICUs). Thisevaluation is of particular interest to clinicians in cardiac ICUs, sincethere is at heightened risk for adverse outcomes. The primary objectivewas to determine the frequency of QT prolongation from potentiallyinteracting drugs in the coronary ICU and cardiothoracic ICU.

ACCP 2011 ANNUAL MEETING ABSTRACTS

METHODS: A retrospective evaluation was performed using theinstitution’s electronic data repository. Inclusion criteria wereadmission to the cardiac ICUs between January 2009 and July 2009,age ≥ 18 years, and electrocardiographic (EKG) evidence of a QTc ≥500 ms. Medications known to prolong the QT interval were identifiedusing the Arizona CERT database. Patients receiving two concomitantmedications known to prolong the QT interval were considered toexperience a pharmacodynamic DDI. Medications known to beCYP450 enzyme inhibitors of QT prolonging medications wereconsidered to cause pharmacokinetic DDIs. Interactions wereevaluated for temporal relationship and causality related to the QTprolongation. RESULTS: 187 (54.5 % male) patients, with a mean age of 62 years,experienced QT prolongation out of a total of 501 patients (37%)admitted during the study period. 154 and 163 patients had a potentialpharmacodynamic and pharmacokinetic interaction, respectively,receiving an average of 2.9 QT prolonging medications during theiradmission. Of these patients, 43% (66/154) had 133pharmacodynamic interactions confirmed by temporal sequence, and47% (77/163) of patients experienced 179 potential pharmacokineticinteractions temporally related to QT prolongation. CONCLUSION: DDIs may be a significant cause of QT prolongationin cardiac ICUs. These data can be used to educate clinicians on safemedication use. Computerized clinical decision support could beapplied to aid in the detection of these events. Published in Published in Crit Care Med 2011;38(12):A89. Presentedat the Society of Critical Care Medicine Annual Critical CareCongress, San Diego, CA, January 15–19, 2011.

5E. Improving adverse drug event detection in critically illpatients through intensive care unit transfer summary screening.Ananth Anthes, Pharm.D.1, Lisa M. Harinstein, Pharm.D., BCPS2,Pamela L. Smithburger, Pharm.D., BCPS3, Amy L. Seybert,Pharm.D.3, Sandra L. Kane-Gill, Pharm.D., MSc, FCCM, FCCP3;(1)University of Pittsburgh Medical Center, Pittsburgh, PA;(2)Cleveland Clinic, Cleveland, OH; (3)University of PittsburghSchool of Pharmacy, Pittsburgh, PA PURPOSE: Hospital discharge notes have been studied as a form ofsurveillance; however, ICU transfer summaries have not been studiedfor this purpose. Improving ADE prevention strategies relies uponimproving detection. METHODS: A retrospective electronic medical record review wasconducted among medical ICU patients. Inclusion criteria includedpatients ≥18 years of age admitted between January through April2009 with an ICU length of stay ≥24 hours. Two scales were utilizedto assess chart documentation for ADEs: 1) Harvard Medical PracticeScale (MPS) and 2) Leonard Evidence Assessment Scale. The HarvardMPS was used to rank the strength of the wording in the medicalrecord with a score of 4 (more than 50-50) up through 6 (virtuallycertain) indicating the presence of an ADE. The Leonard criteria wereused to score causality with 1 out of 4 criteria indicating unlikelypresence of an ADE and 4 out of 4 indicating a definite ADEoccurrence. RESULTS: Demographic information indicates 50% of the patientswere male with a mean age of 60.3 years (+/- 16). 258 unique patientshad ICU transfer summaries screened and evaluated for ADEs. 105patients had at least 1 ADE with a total of 139 ADEs. The HarvardMPS scores collected were 4 (39.6%), 5 (51.8%) and 6 (7.9%). TheLeonard scores were 2 of 4 (17.3%), 3 of 4 (54.7%) and 4 of 4(28.1%). Most common medications associated with an ADE werefurosemide, ciprofloxacin, warfarin and heparin. Most common ADEswere Clostridium difficile, hypotension, acute kidney injury andhyperglycemia. CONCLUSION: 41% of ICU transfer summaries contained adescription of an ADE; therefore, reviewing ICU transfer summariesis a useful method of detecting ICU-specific ADEs and should beconsidered as part of an ADE surveillance system. Understandingcontributing medications and resulting reactions of ADEs will aid infuture prevention strategies. Presented at Presented at the Society of Critical Care MedicineCongress, San Diego, CA, January 15–19, 2010.

6. Glyburide versus glipizide: a comparison of glycemic control in

a selected veteran population. Bharti Sharma, Pharm.D., AnneLubischer, R.Ph., Ronald R. Brown, M.S., R.Ph.; Portland VA MedicalCenter, Portland, OR Glyburide versus Glipizide: A Comparison of Glycemic Control In ASelected Veteran Population. Bharti Sharma, Pharm.D., AnneLubischer, R.Ph., Ronald R. Brown, M.S., R.Ph.; Portland VeteransAffairs Medical Center, Portland, OR. PURPOSE: This study documented HbA1c changes in 70 patientswho were switched to glipizide between August 2009 and January2010 due to concerns of hypoglycemia with glyburide. METHODS: Medical records of these 70 patients at the PortlandVeterans Affairs Medical Center were reviewed to gather HbA1c andweight data up-to a year before the switch and up-to a year after theswitch. Glyburide and glipizide doses and number of other anti-diabetic agents were also collected. Safety endpoints includeddocumented symptomatic hypoglycemia, blood glucose values<60mg/dL and reduction in glipizide dose after the switch. RESULTS: Majority of the patients (54%) were switched to glipizideat doses equivalent to their glyburide dose. Mean daily dose ofglyburide was 8.5mg and glipizide was 9.86mg (P=0.269). The meanconversion ratio was 1mg glyburide to 1.3mg of glipizide. The switchresulted in a mean increase in HbA1c of 0.09% (CI -0.9 to 0.7,p=0.763). The proportion of patients who remained at goal HbA1c of<7% did not change significant after the switch (p=0.986). Change inmean weight was not significant (CI -0.50 to 2.4, p=0.194). Oneincident of symptomatic hypoglycemia was noted before and one afterthe switch. Similarly, one blood glucose value of < 60mg/dL wasdocumented before and one after the switch. Both of these safetyendpoints were under-documented. Only 8.6% of patient needed theiroriginal glipizide dose to be reduced. CONCLUSION: The switch from glyburide to glipizide at equivalentdoses did not result in any negative impact on patients’ glycemiccontrol or adverse effects on their weight. No conclusions regardingsafety outcomes can be made due to lack of documentation. Adult Medicine

7. Evaluation of an ipad to provide warfarin video education inthe inpatient setting. Jenny J. Kim, Pharm.D.1, Rima A. Mohammad,Pharm.D.2, Kim C. Coley, Pharm.D.2, Amy C. Donihi, Pharm.D.2;(1)University of Pittsburgh Medical Center, Pittsburgh, PA;(2)University of Pittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: Traditionally, hospitalized patients receive medicationeducation immediately before discharge by written and/or verbalcommunication. Improving patient education about warfarin therapy isimportant because warfarin is among the top 10 medications with thelargest number of reported adverse events. This quality improvementproject evaluated the use of an iPad to provide video education toimprove patient education regarding warfarin therapy. METHODS: This project was prospectively conducted to includeadult (>18 years of age) hospitalized patients on warfarin. Patientscompleted pre- and post-test knowledge questionnaires on the iPadbefore and after viewing the warfarin educational video. The primaryobjective was to evaluate the use of a warfarin educational video as aneffective tool on an iPad. The secondary objective was to evaluatepatients’ satisfaction with using an iPad to view the warfarin video andcomplete the questionnaires. RESULTS: A total of 40 patients were educated and included forevaluation. Most patients were new to warfarin therapy (65%). For theprimary outcome of warfarin knowledge test scores, 42.5% of patientspassed the pre-test and 90% of patients passed the post-test, p<0.001.There were no significant differences observed among test scoreswhen comparing by age, gender, level of education, and use of CNSdepressant drugs. Overall, 82.5% of patients reported they liked usingthe iPad and it was easy to use. A greater percent of younger patients(< 65 years) and females liked using the iPad compared to olderpatients (p=0.01) and males (p=0.02), respectively. Also, more patients< 65 years reported the iPad was easy to use compared to olderpatients, p=0.01. CONCLUSION: Providing warfarin video education to hospitalizedpatients using an iPad was effective. The knowledge questionnaireidentified concepts patients did not understand and prompted furtherdiscussion. Educating patients by video using an iPad may be analternative to traditional education.

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8. Evaluation of a pharmacy-driven renal dosing program.Katherine J. Rable, Pharm.D., Andrew J. Crannage, Pharm.D., BCPS;St. John’s Mercy Medical Center and St. Louis College of Pharmacy,St. Louis, MO PURPOSE: The objective of this study was to determine the impactof a pharmacy-driven renal dosing program on appropriate dosing ofmedications. METHODS: In April 2010, St. John’s Mercy Medical Centerimplemented a pharmacy-driven renal dosing program forlevofloxacin and piperacillin/tazobactam allowing pharmacists toindependently adjust dosage and/or frequency of these medicationsbased on a patient’s renal function, estimated via the Cockcroft-Gaultequation. An investigation was conducted to evaluate this program.Patients hospitalized during September 2009 (pre-implementation) orSeptember 2010 (post-implementation) who received IV levofloxacinand/or IV piperacillin/tazobactam and had a serum creatininemeasured prior to medication initiation were included. RESULTS: One hundred patients were included in the pre-implementation group [levofloxacin (n=50), piperacillin/tazobactam(n=50)] and 100 patients were included in the post-implementationgroup [levofloxacin (n=50), piperacillin/tazobactam (n=50)]. Therewas no significant difference in mean age, mean creatinine clearance(CrCl), percentage of female patients, or percentage of patients onhemodialysis between groups. The percentage of patients most likelyto require a renal adjustment to their therapy (CrCl <50mL/min) wassimilar between the pre- and post-implementation groups at 42% and44%, respectively (p=0.89). Seventy-nine percent of patients in thepre-implementation group (levofloxacin 66%; piperacillin/tazobactam92%) were dosed appropriately compared to 94% in the post-implementation group (levofloxacin 90%; piperacillin/tazobactam98%), (p=0.0032).CONCLUSION: Implementation of a pharmacy-driven renal dosingprogram significantly improves appropriate dosing of levofloxacin andpiperacillin/tazobactam. Additional pharmacist education will benecessary to ensure that appropriate dosing continues to improve.Based on these findings, pharmacist autonomy to independently adjustdosages and/or frequencies, with an institution approved protocol,could be expanded to other renally-eliminated medications to improveappropriate dosing. Expansion of this program would also allowpharmacists to further apply clinical knowledge to optimize patientcare. An evaluation specifically designed to evaluate potential cost-savings would provide additional justification for expansion.

9. Risk factors for venous thromboembolism in patients withcirrhosis. Kelly A. Walsh, Pharm.D.; University of KentuckyHealthCare, Lexington, KY PURPOSE: Pharmacologic venous thromboembolism (VTE)prophylaxis in patients with cirrhosis presents a unique challenge dueto complications associated with the disease, including esophagealvarices, thrombocytopenia and elevated international normalizedratios (INR). When evaluating whether these patients require VTEprophylaxis upon hospitalization, practitioners must weigh the risk ofbleeding, and their perceived ‘auto-anticoagulation’, against the riskof developing VTE. Therefore, it would be advantageous if riskfactors for the development of VTE in this population were identified.This study was designed to identify risk factors associated with thedevelopment of VTE in cirrhotic patients. METHODS: This study is a retrospective, case control study. Patientsat the University of Kentucky Chandler Hospital with a diagnosis ofcirrhosis and VTE from October 2006 to July 2010 were matched in a1:3 fashion with cirrhotic patients without VTE. The primary objectivewas to determine if there were significant differences in laboratoryvalues between the 2 groups. Secondary objectives include examiningthe relationship between VTE incidence and INR. RESULTS: During this time period, 27 patients with cirrhosis (1.0%)were diagnosed with VTE. These patients had significantly lowermedian aspartate aminotransferase (AST) (47 U/L versus 70, p=0.04),alanine transaminase (ALT) (24.5 U/L versus 36, p=0.02), albumin(2.1 g/dL versus 2.4, p=0.02) and hematocrit (28.3% versus 32,p=0.03) compared to the control patients. There was no correlationbetween INR and VTE incidence (p=0.70). CONCLUSION: Patients with cirrhosis who developed VTE hadsignificantly lower AST, ALT, albumin, and hematocrit, compared to

control patients. There was no correlation between INR and VTEincidence. Therefore, in the absence of contraindications, use ofpharmacological VTE prophylaxis in non – ambulating, hospitalizedcirrhotic patients should be considered.

10. As needed intravenous antihypertensive therapy and bloodpressure control. Melissa Lipari, Pharm.D.1, Lynette R. Moser,Pharm.D.2, Elizabeth A. Petrovitch, Pharm.D., BCPS1, Margo Farber,Pharm.D.3, John Flack, M.D., MPh4; (1)Harper University Hospital,Detroit, MI; (2)Wayne State University, Eugene Applebaum Collegeof Pharmacy and Health Sciences, Detroit, MI; (3)Detroit MedicalCenter, Detroit, MI; (4)Wayne State University School of Medicine,Detroit, MI PURPOSE: As needed intravenous antihypertensive therapy (IVAHT)is not indicated for asymptomatic blood pressure (BP) elevations orhypertensive urgencies. This study describes IVAHT use and theimpact on asymptomatic patients. METHODS: We conducted a prospective chart review ofhypertensive patients who were prescribed as needed or one time onlyIV hydralazine, enalapril, labetalol or metoprolol between November2010–January 2011. Data obtained through the electronic medicalrecord included demographics, oral antihypertensive regimen changesduring admission and at discharge, the prescriber type, IVAHT drugprescribed, type of order, whether the ordered drug was administered,BP and heart rate. The frequency of IVAHT related adverse outcomeswas also assessed. RESULTS: 247 patients were prescribed an IVAHT, 166 (67%)patients received IVAHT and 81 (33%) did not. Average baseline BPwas higher in the administered vs. the not administered group,162.1±2/86.96 vs. 151.7/83.33 mmHg, respectively (p = 0.011).Hydralazine represented 81% of orders, metoprolol 15% and labetalol4%. Residents were the most common prescribers (48%), followed byphysician’s assistants/nurse practitioners (37%) and attendingphysicians (15%). After IVAHT administration only 42% of patientsreceived a change to their oral antihypertensive regimen and 48% hadchanges to their oral regimen at discharge. BP was lowered morebetween admission and discharge in patients who experienced achange in their oral antihypertensive regimen after IVAHTadministration compared to those who did not. Adverse events within6 hours of IVAHT administration were: 14.4% decreased BP >25%baseline, 1.4% tachycardia, 0.8% bradycardia, 0.6% IV fluidadministration, 1.7% scheduled BP medication held. CONCLUSION: IVAHT is used in patients with BP elevations belowminimum thresholds for hypertensive urgencies. Excessive BPlowering occurs in a significant proportion of those receiving IVAHT.The majority of patients receiving IVAHT have no changes made totheir oral AHT regimen.

11. Pharmacy department commitment to a multidisciplinarystroke response team. Matthew J. Korobey, Pharm.D., BCPS1,Andrew J. Crannage, Pharm.D.2, Julie A. Murphy, Pharm.D., BCPS2,Judd Jensen, M.D.1, B.J. Hipsky, RN, MSN1; (1)St. John’s MercyMedical Center, St. Louis, MO; (2)St. Louis College of Pharmacy andSt. John’s Mercy Medical Center, St. Louis, MO PURPOSE: On August 15, 2010, a multidisciplinary (neurology,interventional radiology, pharmacy, and nursing) stroke response team(SRT) was implemented at St. John’s Mercy Medical Center. Theobjective of this study was to determine 1) the number of stroke callsreceived, 2) the average and total duration of time devoted to strokecalls, and 3) the difference in the absolute number of stroke calls withregards to time of day after implementation of a multidisciplinarySRT. METHODS: Data was collected on each individual response of themultidisciplinary SRT for patients presenting with symptoms of acuteischemic stroke from August 15, 2010 through May 31, 2011. Thisdata included absolute number of SRT activations, pharmacist timespent per stroke team response, if tissue plasminogen activator (t-PA)was administered, and shift during which the SRT was activated. RESULTS: During the first 9.5 months following implementation ofthe multidisciplinary SRT, 224 responses were required. An average of24 minutes of pharmacist time was required per SRT activation,resulting in an overall time commitment of 570 minutes per month.Twenty-five (11%) SRT activations resulted in patients receiving t-PA.


SRT activations resulting in t-PA administration required an average of64 minutes of pharmacist time devoted to patient/disease assessment,dose calculation, verification, and medication preparation. Fifty-onepercent of these responses occurred during day-shift, 42% duringevening-shift, and 7% during night-shift. CONCLUSION: Implementation of a multidisciplinary SRT, toimprove care of the acute ischemic stroke patient, requires acommitment from clinical pharmacy and the department of pharmacyas a whole. Requiring 24-hour pharmacy coverage of the SRT pager,increases opportunities for application of clinical skills by allpharmacists to optimize patient care. Non-captured pharmacy timeincludes training of department staff and residents by clinicalpharmacy specialists.

Ambulatory Care

12. Impact of change in duration of therapy with Ursodiol aftergastric bypass surgery. Margaret Malone, Ph.D., FCCP1, JenniferLindstrom, M.D.2, Christine Gallati, B.S.2; (1)Albany College ofPharmacy and Health Sciences, Albany, NY; (2)Albany MedicalCollege, Albany, NY PURPOSE: Ursodiol is commonly used after gastric bypass surgeryto reduce the formation of gallstones associated with rapid weight lossexperienced in the first post operative year. The duration of therapyvaries between centers from no therapy to up to 12 months. METHODS: IRB approval to conduct a retrospective chart reviewwas obtained. The incidence and time of occurrence of gallstones andassociated cholecystectomy (CCY) between 1/2006 and 4/2009 (40months) when patients were prescribed 12 months of therapy werecompared with the period 5/2009 to 4/2011 (24 months) during whichpatients were prescribed 6 months of therapy. All patients underwentRoux-en-Y gastric bypass (RYGB). RESULTS: 513 patients were included in the first study period (xfemales). 93 patients had CCY at the same time as the RYGB (18.1%).29 (5.5%) patients developed gallstones and had CCY after surgery[2/29 had CCY within 90 days of RYGB]. 16/29 developed gallstonesin the first post operative year. The mean (SD) time to CCY was 520(400) days, range 16–1649 days. In the second study period, 351patients (x females) had RYGB, 39 (11.1%) had CCY at the time ofRYGB. 14 (4%) patients had CCY for gallstones after RYGB. Themean (SD) time to CCY was 216 (165) days, range 4–537 days. 6/14developed gallstones while taking ursodiol in the first 6 months, [4within 90 days of RYGB]. 4/14 developed gallstones after one year. CONCLUSION: Patients in both groups developed gallstones duringtreatment and after the ursodiol was discontinued. The percent ofpatients developing gallstones was similar between groups. Patients inthe second group developed gallstones earlier. Reducing the durationof therapy did not adversely affect the number of patients requiringpost RYGB CCY.

13. Effectiveness of dietary sodium intervention provided by aclinical pharmacist to ambulatory patients with heart failure.Grace L. Earl, Pharm.D.1, Annette Lista, Pharm.D., candidate1, SusanYoussef, Pharm.D., candidate1, Laura Pontiggia, Ph.D.2, AndrewPeterson, Ph.D.3; (1)University of the Sciences, Philadelphia Collegeof Pharmacy, Philadelphia, PA; (2)University of the Sciences, MisherCollege of Arts and Sciences, Philadelphia, PA; (3)University of theSciences, Mayes College of Healthcare Business and Policy,Philadelphia, PA PURPOSE: Evaluation of the impact of a clinical pharmacistintervention to promote dietary sodium adherence. METHODS: A prospective interventional cohort study enrolled adultpatients and engaged them during 4 meetings lasting 15–30 minutes (2face-to-face, 2 phone calls). The intervention was designed to enhanceunderstanding of dietary overindulgences and impact on heart failure.Four 24-hr dietary recalls were used to counsel on low-sodium foodchoices and achieving sodium intakes under 2000 mg per day. Dataare presented as the mean (95% CI) and were analyzed with a paired t-test. LOCF was used for missing data, and IRB approval wasobtained. RESULTS: Thirty-six patients were enrolled and 33 completed thestudy (mean age 52.1 years, 82% African-American, and mean EF32.3%). All 4 dietary recalls were obtained in 89.1% of patients.

Baseline sodium intake was 1987.4 mg (95%CI 1580.6–2394.2) and1591.2 mg (95%CI 1249.4–1933.1) at follow-up demonstrating a19.9% relative reduction in dietary sodium intake (p > 0.05). Therewas no difference in vital signs at follow-up. The percent of patientsreporting medication adherence was 51.5% at baseline versus 65.6%at follow-up. The incidence of heart failure hospitalizations in prior 6months was 51.5% at first meeting and 18.8% at follow-up (p=0.009,Fisher’s exact test). CONCLUSION: This educational program can serve as a model forclinical pharmacists who are engaged in providing services to patientswith cardiovascular disease or other conditions where excessivedietary sodium intake can adversely affect their medical condition.New guidelines promote dietary sodium goals under 1,500 mg formany groups, and we encourage development of teaching tools andself-care tools to engage patients in adopting healthy dietary lifestyles.

14. Assessment of insulin pens in an urban teaching hospitaloutpatient clinics. Andrea R. Gauld, Pharm.D.1, Brigitte L. Sicat,Pharm.D.2, Brian Baird, Pharm.D.1; (1)Virginia CommonwealthUniversity Health System, Richmond, VA; (2)VirginiaCommonwealth University School of Pharmacy, Richmond, VA PURPOSE: Insulin pens were added to the Virginia CommonwealthUniversity Health System (VCUHS) drug formulary in June 2010. Theavailability of insulin pens to patients may improve adherence andglycemic control, however, patients must be educated on proper use ofthe pen device. The objective of this project is to determine if therewas a change in A1c or insulin utilization when patients were switchedfrom insulin vials to pens, and to describe patients’ knowledge ofproper use of insulin pen devices. METHODS: A retrospective review was conducted of all patientsswitched from receiving vials to pens at VCUHS outpatientpharmacies from January 1, 2009 to February 28, 2011. Additionally, atelephone survey was attempted on all patients who filled aprescription for an insulin pen from June 1, 2010 to February 28,2011. RESULTS: There were 31 patients included for medical recordevaluation. From the January 1, 2009 start date, patients received vialsfor an average of 14.7 months before transitioning to pens for anaverage duration of five months of pen use during the study period.The A1c decreased from 9.55% to 9.03% (p=0.11) and average insulinutilization significantly increased in patients from 63 to 85 units perday (p<0.01). Twenty-one patients participated in the telephonesurvey: 38% of patients did not prime the insulin pen prior to eachdose and 34% of patients did not properly dispose of pen needles.Patients were educated by a variety of sources: nurses (38%), packageinsert (24%), pharmacists (24%), and physicians (14%). CONCLUSIONS: Changing patients to insulin pens significantlyincreased insulin utilization but did not have a significant impact onA1c. Patients may require more comprehensive insulin pen teachingupon initiation and/or reassessment of proper pen use over time.

15. Homeless and housed patients’ access to treatment at apharmacist-led smoking cessation clinic. Sharon E. Connor,Pharm.D.1, Deborah M. Scharf, Ph.D.2, Lauren J. Jonkman, Pharm.D.,BCPS1, Mary I. Herbert, M.S., M.P.H.3; (1)University of PittsburghSchool of Pharmacy, Pittsburgh, PA; (2)Department of Psychiatry,University of Pittsburgh and RAND Corporation, Pittsburgh, PA;(3)UPMC Department of General Internal Medicine, Pittsburgh, PA PURPOSE: Although homeless adults report wanting to quit smokingat rates similar to their housed peers, the prevalence of smokingamong the homeless remains disproportionately high. Few studieshave investigated the role that pharmacists might play in promotingsmoking cessation among the homeless. To address this need, wecompared housed and homeless persons’ access to, and use of apharmacist-led smoking cessation clinic for the homeless andmedically underserved. METHODS: Participants were homeless (n=260) and housed (n=226)medically underserved adults who received services at theBirmingham Free Clinic between April 2010 to December 2010. Datacollection began immediately following implementation of newscreening, referral and treatment procedures designed to promoteparticipation in the smoking cessation program. All clinic patientswere to be asked about their smoking status, advised to quit and

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referred to the smoking cessation service (a 9-session smokingcessation counseling protocol with free nicotine replacement therapy). RESULTS: Overall 97% of the sample had their smoking statusassessed. Smoking was more common among the homeless (vs.housed) patients (59% vs. 39%; p<0.008). Among current smokers,there were no between-group differences in cigarettes smoked per day,breath CO, readiness to quit smoking (all p’s > 0.14). There were alsono between-group differences in receipt of advice to quit smoking(84% vs. 78%; p=0.79) or referral to the treatment program (39% vs.31%; p=0.46). Among clients receiving a referral to treatment,homeless clientele were half as likely to attend at least one treatmentsession (18% vs. 37%; p=0.15). CONCLUSION: We did not identify disparities in homeless clients’access to screening or referrals. However, homeless clients were halfas likely to attend treatment once a referral was made. Supplementalstrategies to increase treatment utilization may be needed to improvehomeless clients’ treatment attendance and retention in smokingcessation programs.

16. Malignancy and warfarin-mediated anticoagulation: lowerinitial dose requirements, but greater long-term instability,adverse events, and intensity of management. Holly H. Chiu,Pharm.D.1, Megan B. Bestul, Pharm.D.1, Peter Whittaker, Ph.D.2;(1)Beaumont Hospital, Royal Oak, MI; (2)Wayne State UniversitySchool of Medicine, Cardiovascular Research Institute and Dept ofEmergency Medicine, Detroit, MI PURPOSE: Emerging evidence indicates METHODS: Our retrospective chart-review, examined 20 RESULTS: Initial: There was no difference in time to achieve targetINR, however, cancer patients required a lower daily dose than thecomparison group (7.5±2.8 vs. 4.7±1.9mg; P=0.002). Long term:cancer patients were unstable; indicated by lower TTR (48±15 vs.79±10%; P<0.0001), and fewer INRs within target range (46±14 vs.74±8%; P<0.0001). Furthermore, cancer patients required increasedmanagement; double the proportion of visits which required dosechanges (43±16 vs. 20±7%; P<0.0001) and one week less betweenvisits (10±19 vs. 17±26 days; P<0.0001). Cancer patients experienceda 10-fold increase in the proportion of visits with AE (6.0±8 vs.0.6±1%; P=0.0039); AE correlated inversely with TTR (P=0.006). CONCLUSIONS: Cancer patients’ initial

17. Use of low molecular weight heparin (LMWH) in pregnancy: apharmacodynamic modeling study. Tara E. Gleason, Pharm.D.1,Nancy L. Shapiro, Pharm.D.1, Larisa H. Cavallari, Pharm.D.1, Edith A.Nutescu, Pharm.D.1, Michelle Kominiarek, M.D.2, Judith U. Hibbard,M.D.2; (1)University of Illinois at Chicago College of Pharmacy,Chicago, IL; (2)University of Illinois College of Medicine, Chicago,IL PURPOSE: Low molecular weight heparins (LMWH) are the maintreatment option for women needing anticoagulation duringpregnancy. Guidelines for dosing LMWH in pregnancy exist, howeverthere is no clear recommendation for the need and frequency ofmonitoring of anti-Factor Xa activity. The pharmacokinetics ofLMWH are altered significantly during pregnancy, with increasedrenal clearance and volume of distribution. Pharmacodynamic data isneeded to support the pharmacokinetic data that already exists forLMWH. METHODS: A consecutive cohort of pregnant women who receivedLMWH therapy during pregnancy and delivered between January 1,1998–November 1, 2010 were included in the study. Data wasextracted through review of the electronic medical records. Theprimary outcome was to determine the pharmacodynamics of LMWHin pregnancy. The dosing requirements of LMWH for each casethroughout pregnancy (mg/kg) to achieve a corresponding target anti-Factor Xa activity were plotted and linear correlation coefficients werecalculated. Secondary outcome measures included frequency ofmonitoring of anti-Factor Xa activity, thromboembolic events, andbleeding complications with LMWH use in pregnancy. RESULTS: A total of 115 consecutive patients (123 pregnancies)were included. Average age was 28.4 years (16–45) and 45% ofpatients had a pre-pregnancy BMI > 30. The majority of patients wereBlack or Hispanic. There were 66 pregnancies involving prophylaxisindications and 57 pregnancies involving treatment indications for

LMWH. Calculations of the mg/kg dose requirement throughoutpregnancy to achieve the targeted anti-Factor Xa activity showednonlinear dosing requirements for all groups with the followingcorrelation coefficients: all treatment(r=0.086), all prophylaxis(r=0.001), obese treatment (r=0.154), nonobese treatment (r=0.029),obese prophylaxis (r=0.25), nonobese prophylaxis (r=0.01). CONCLUSION: Initial pharmacodynamic modeling showed poorlinear correlation for all groups of patients when comparing dosingrequirements with week of pregnancy, supporting the need for furtherstudies with non-linear modeling methods and monitoring anti-FactorXa activity throughout pregnancy.

18. Increased Goal Attainment After Conversion FromRosuvastatin to Simvastatin in a Community Health Clinic. JoelC. Marrs, Pharm.D., BCPS1, Sarah L. Anderson, Pharm.D., BCPS1,Karen E. Snow, Pharm.D.2, Joseph J. Saseen, Pharm.D., FCCP,BCPS1; (1)University of Colorado School of Pharmacy, Aurora, CO;(2)Denver Health Medical Center, Denver, CO PURPOSE: This retrospective observational cohort study evaluatedLDL-C goal attainment before and after implementation of atherapeutic statin conversion among patients with dyslipidemia in acommunity health clinic. Secondary endpoints included LDL-C goalattainment stratified by cardiovascular risk, number of equipotentconversions, changes in other lipoprotein values, and financial impact. METHODS: Refill records for adults with a prescription forrosuvastatin between June 1, 2009 and November 24, 2009 identifiedpatients for conversion to simvastatin. Patients who were eligible forconversion were included in this analysis. Patient demographics, costdata, fasting lipid panel (FLP) and alanine aminotransferase (ALT)results were collected. RESULTS: One hundred sixty-six patients were eligible forconversion from rosuvastatin to simvastatin. Seventy-five of thesepatients (45.2%) received a follow-up FLP and further analysis. LDL-C goal attainment increased from 64.0% at baseline to 82.7% afterconversion (p=0.001). When stratified by cardiovascular risk, 100% oflow- and moderate-risk, 79.4% of high-risk and 57.1% of very high-risk patients attained goal LDL-C post conversion (p=0.002). Sixty-three patients (84.0%) were converted using an equipotent dose and 12(16.0%) required conversion with dose titration by the clinicalpharmacist. Average LDL-C was 85.3±38.5 mg/dL at baseline and80.2±30.6 mg/dL after conversion (p=0.29). Average non-HDL-C was116.2±36.0 mg/dL at baseline and 110.0±28.8 mg/dL after conversion(p=0.09). All other lipoprotein and ALT values were not statisticallydifferent pre- and post-conversion. Cost data demonstrated a savingsof $13,500 for the community health clinic over a 12 month period forthe 75 patients with follow-up FLPs. CONCLUSION: A therapeutic substitution protocol that includedindividual patient assessment by a clinical pharmacist is an effectivestrategy for converting patients from a high- to medium-potencystatin. This approach maintained therapeutic efficacy and resulted inboth an improvement in LDL-C goal attainment and cost savings.

19. Evaluation of two education methods for patient knowledge inpatients recently started on warfarin. Lisa Potts, Pharm.D., BCPS,Cari Cristiani, Pharm.D., BCPS, Jun-Yen Yeh, Ph.D.; ClevelandClinic, Cleveland, OH PURPOSE: In order to maximize clinic efficiency while maintainingquality education, this study was done to compare anticoagulationknowledge levels in patients before and after two differentanticoagulation education methods. METHODS: This study was approved by the IRB. Newly referrednaïve (warfarin use for <2 months) anticoagulation patients weregiven warfarin education via face-to-face pharmacist counseling(group I) or video education (group II). Patients were given the ShortAnticoagulation Knowledge Test (SOAK), a previously validatedinstrument, before and after education. A sample size of 106 patientswas required to detect a 15% change in knowledge with 80% powerand alpha of 0.05. RESULTS: A total of 108 (54:54) patients were enrolled. Baselinedemographics were similar between groups with 52.3% female, 52.8%over 65 years old and 67.9% with high school or some collegeeducation. The SOAK scores prior to educational intervention weresimilar between the groups (p=0.383) and were significantly improved


after education intervention (group I: 55.9%±26% to 75.8%±21%,p<0.001; group II: 60.4%±26% to 70.7%±22%, p=0.030). The meanchange in pre-post SOAK scores was significantly higher in group I(+21%±23%) than in group II (+10%±23%, p=0.011). However, thepost-education SOAK scores were not significantly different betweengroups (p=0.228). CONCLUSIONS: Patients receiving warfarin education via videohad similar post-education warfarin knowledge score to patientsreceiving face-to-face warfarin education. This may allowanticoagulation clinics to effectively and efficiently provide warfarineducation in a busy anticoagulation clinic.

20. Impact of a Medication Therapy Management Program onHemoglobin A1c Values in a Health Resources and ServicesAdministration Patient Safety and Clinical Pharmacy ServicesCollaborative. Heather B. Congdon, Pharm.D.1, Iliana Cheng,Pharm.D.1, Hoai An Truong, Pharm.D.2, Faramarz Zarfeshan, R.Ph.3,Thomas C. Dowling, Pharm.D, Ph.D4; (1)University of MarylandSchool of Pharmacy, Rockville, MD; (2)University of MarylandSchool of Pharmacy, Baltimore, MD; (3)ALFA Specialty Pharmacy,Silver Spring, MD; (4)University of Maryland, School of Pharmacy,Baltimore, MD PURPOSE: To evaluate the impact of Medication TherapyManagement (MTM) visits on diabetes control in patients enrolled inan underserved, safety-net clinic participating in the Health Resourcesand Services Administration (HRSA) Patient Safety and ClinicalPharmacy Services Collaborative (PSPC). METHODS: Patients with type 2 diabetes who received pharmacy-based MTM during the period of October 1, 2009 and March 31, 2011were included. Pharmacist interventions included a medicationtherapy review and diabetes education as appropriate. Writtensummaries of pharmacists’ findings and recommendations wereprovided to physicians prior to physician-patient encounter. Baselinevalues were collected within 3 months prior to the first MTMencounter. Post-MTM A1c values were collected at least 3 monthsafter the last MTM visit. Patients were stratified by frequency ofMTM visits. Pre and post-A1c values in each group were comparedusing Wilcoxon signed rank or Mann Whitney U, where appropriate. RESULTS: A total of 64 patients had at least 1 MTM visit with pre-and post-MTM A1c data. The A1c for all patients decreased from8.1% to 7.8% (95% CI: -0.73, 0.06; p=0.1127). Of the 35 patients whoparticipated in only one MTM visit, the values decreased from 7.4%to 7.3% (95% CI: -.06024, 0.4538, p=0.93). Of the 29 patients whoparticipated in at least two MTM visits (range: 2–6 visits), valueswere significantly reduced from 9.0% to 8.3% (95% CI: -1.263,0.03336, p=0.02). Pre values were significantly higher in the multipleMTM group compared to the single visit group (9.0±2.0 7.4±1.5,respectively, p<0.001). CONCLUSIONS: Patients enrolled in a HRSA PSPC safety-netclinic having multiple interactions with an MTM pharmacist are morelikely to have a higher baseline , but a larger reduction in A1c thanthose without repeat MTM visits.

Cardiovascular

21E. Lipid Target Attainment by Switching Statin Monotherapy toFenofibric Acid + Statin in Patients With Mixed Dyslipidemia andat High-/Highest-Risk for Coronary Heart Disease. Peter H. Jones,M.D.1, Syed M. Mohiuddin, M.D.2, Christie M. Ballantyne, M.D.1,Michael H. Davidson, M.D., FACC, FACP3, Kamlesh Thakker,BPharm, Ph.D.4, Carolyn M. Setze, M.S.4, Aditya Lele, M.S.4,Maureen T. Kelly, M.D.4; (1)Baylor College of Medicine, Houston,TX; (2)Creighton Cardiac Center, Omaha, NE; (3)University ofChicago, Pritzker School of Medicine, Chicago, IL; (4)Abbott, AbbottPark, IL PURPOSE: This post hoc analysis evaluated attainment ofindividual/combined target levels of LDL-C, non-HDL-C and Apo Bfollowing 52-week treatment with open-label fenofibric acid (FA) +moderate-dose statin (MDS) in patients with mixed dyslipidemiapreviously treated with statin monotherapy for 12 weeks. METHODS: Patients included were at high risk for coronary heartdisease (CHD or CHD risk equivalent, including diabetes) or highestrisk (a subset of the high-risk group with diabetes + CHD, or diabetes

+ 10-yr CHD risk >20%), were treated with statin monotherapy(rosuvastatin 10, 20 or 40 mg; simvastatin 20, 40 or 80 mg; oratorvastatin 20, 40 or 80 mg) for 12 weeks in 1 of 3 controlled studiesand subsequently treated with open-label FA 135 mg + MDS(rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg) for 52weeks, and had lipid/lipoprotein values both at baseline (start of open-label extension) and Week 52. Target levels were defined in high-/highest-risk patients as LDL-C <100/<70 mg/dL, non-HDL-C<130/<100 mg/dL, and ApoB <90/<80 mg/dL. McNemar’s test wasused for comparisons. RESULTS: At Week 52 compared with baseline, FA + MDS resultedin a similar % of high-risk patients achieving LDL-C target (N=204,72.1% vs 74.0%, P=0.652), a significantly greater % achieving targetlevels of non-HDL-C (N=204, 75.5% vs 63.2%, P<0.001), Apo B(N=203, 70.0% vs 56.7%, P<0.001), and significantly greater %achieving all combined targets (P <0.05). A numerically greater % ofhighest-risk patients (N=26) achieved LDL-C (38.5% vs 26.9%), non-HDL-C (38.5% vs 23.1%), ApoB (46.2% vs 38.5%), and combinedtargets at week-52 vs baseline (P>0.05 for all). CONCLUSION: In high-/highest-risk patients previously treatedwith statin monotherapy for 12 weeks, long-term FA + MDS resultedin greater percentages of patients attaining LDL-C (highest-risk only),non-HDL-C, Apo B and combined targets of these parameters. Published in Journal of Clinical Lipidology 2011;5:202–203

22E. Long-Term Efficacy and Safety of Fenofibric Acid inCombination with Statins in Patients with Mixed Dyslipidemiaand Type 2 Diabetes Mellitus. Maureen T. Kelly, M.D.1, Kamlesh M.Thakker, BPharm, Ph.D.1, Carolyn M. Setze, M.S.1, Inderjit S.Mandair, M.D.2, Patrick Aubonnet, M.D.2; (1)Abbott, Abbott Park, IL;(2)Abbott, Allschwil, Switzerland PURPOSE: Mixed dyslipidemia (MD) characterized by elevatedLDL-C and triglycerides (TG) and low levels of HDL-C is common inpatients with type 2 diabetes mellitus (T2DM). Short-term treatmentwith fenofibric acid (FA) + statin comprehensively improves multiplelipid parameters more effectively than either monotherapy in patientswith MD and T2DM. The long-term efficacy and safety of FA + statinin this population was assessed. METHODS: Patients included had MD and T2DM, completed 12weeks treatment in 1 of 3 controlled studies (evaluating FA + statin vscorresponding-dose monotherapies), and subsequently were treatedwith open-label FA 135mg + moderate-dose statin (simvastatin 40 mg,atorvastatin 40 mg, or rosuvastatin 20 mg) for 52 weeks. Efficacymeasurements were pooled across treatment groups and werecalculated from baseline (start of the controlled studies) to specifictime points across the controlled and open-label studies. Adverseevents occurring during either the controlled studies or the extensionstudy were included in the safety analysis. RESULTS: A total of 413 patients with MD and T2DM receivedcombination therapy and were included in this analysis. Treatmentwith FA + moderate-dose statin led to improvements in all efficacyvariables that were sustained over 52 weeks of the extension study.Mean % changes from baseline to week 64 were: LDL-C (-43.0),HDL-C (+17.9), non-HDL-C (-47.5), Total-C (-37.7), VLDL-C (-50.0), and ApoB (-43.8). Median % changes from baseline to week 64in TG and hsCRP were -50.3 and -32.6, respectively. Overall, 117(28.3%) patients experienced treatment-related adverse events (AEs),and 49 (11.9%) patients discontinued therapy due to an AE. No casesof rhabdomyolysis or treatment-related deaths were reported. CONCLUSION: Long-term therapy with FA + statin resulted insustained improvements in multiple lipid values and was generallywell tolerated in patients with MD and T2DM. Published in Will be presented at American Diabetes Association(ADA) 2011, June 24–28, San Diago, and published in JuneSupplement Diabetes 2011

23. Dose escalation of b-Blocker Therapy Following Initiation ofCardiac Resynchronization Therapy. Frank A. McGrew, M.D.1, EricE. Johnson, M.D.1, Mark A. Coppess, M.D.1, Jessica Foon, B.S.1,Thomas A. Charlton, B.S.2, Sandy Charlton, BSN2, J. Jason Sims,Pharm.D.2; (1)Stern Cardiovascular Foundation, Germantown, TN;(2)Medtronic, Mounds View, MN PURPOSE: Many trials show that b-blockers reduce morbidity and

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mortality at specific target doses. However, beta blocker doseescalation is limited due to several factors including heart rate,hemodynamic status, and whether a dedicated heart failure (HF)cardiologist is involved in the management of the patient. In patientsindicated for cardiac resynchronization therapy (CRT), the addition ofpacing and improved hemodynamics may allow for b-blocker doseescalation. We sought to determine the percent of target b-blockerdose in patients managed by general cardiologist and a HF dedicatedcardiologist before and after CRT at a large, private practicecardiology clinic. METHODS: A retrospective analysis of our CRT database wasperformed in December 2010. All patients with an FDA approvedCRT device were evaluated. The date of first CRT implant wasdocumented along with the dose of b-blocker prior to implant. Thedose of b-blocker at last follow up visit was also documented. b-blocker doses were normalized as percent of target dose based ontarget doses from published trials. RESULTS: HF cardiologist patients (n=135) averaged 70+66% oftarget b-blocker dose pre-implant. Following CRT implant, HFcardiologist patients averaged 104+74% of target b-blocker dose(p=0.0001). General cardiologist patients (n=226) averaged 39 ± 40%of target dose pre-implant and 49±41% of target dose post-implant(p=0.008). The percent b-blocker target dose increase post-implantwas significantly greater by the HF cardiologist (34% versus 10%,p=0.0007). CONCLUSION: b-blocker dose escalation can be accomplished afterCRT implant by both general and dedicated HF cardiologists andshould improve patient clinical status. This dosage increase may bemore pronounced with a dedicated heart failure cardiologist involvedin the management of the patient. Patients managed by generalcardiologists and a HF dedicated cardiologist before and after CRT ata large, private practice cardiology clinic.

24. The antiplatelet effects of sustained-release niacin. MatthewAgosti, Pharm.D., Nicholas Bacon, Pharm.D., Candidate, Nicholas B.Norgard, Pharm.D.; University at Buffalo- School of Pharmacy andPharmaceutical Sciences, Buffalo, NY PURPOSE: Heightened platelet reactivity is an independent predictorof poor outcome following an acute coronary syndrome.Contemporary antiplatelet agents may not always be sufficient toprovide therapeutic platelet inhibition. This has inspired clinicalinvestigation into the use of alternative and/or adjunct agents tointensify platelet inhibition. Niacin is used for the modulation ofcholesterol but may also have antiplatelet effects. This studyinvestigated the ability of niacin to inhibit platelet aggregation. METHODS: Part I: Blood samples were drawn from normalvolunteers at baseline and then 1 hour after the administration of 1gram of sustained-release niacin. Part II: Blood samples were drawnfrom normal volunteers at baseline and then 12 hours after theadministration of 2 grams of sustained-release niacin. Plateletaggregation was measured using the RESULTS: A significant 26% reduction in collagen-inducedaggregation and a 7% reduction in ARU

Baseline Mean

(mean±ISD Post-Niacin Change p-value

1-hr Results

Collagen (ohms) 19.4 ± 1.7 14.38 ± 2.9 5.0 p=0.0275(1.05 to 8.95)

Aspirin (ARU) 622.4 ± 7.3 582.3 ± 46.4 40.1 p=0.0311 (4.8 to 75.4)

12-hr Results

Collagen (ohms) 15.8 ± 2.5 14.1± 3.3 1.6 P=0.051 (-0.007 to 3.3)

Aspirin (ARU) 630 ±26 630 ±22 -0.36 p=0.48(-19.6 to 18.9)

CONCLUSION: Niacin has a small, direct effect on plateletaggregation. The platelet inhibition is transient as it is no longerevident 12 hours after drug administration. The clinical significance ofniacin’s antiplatelet effect remains unknown.

25E. Aspirin reduces transient flushing and glucose increasesduring therapy with niacin extended-release. Robert J. Padley,M.D.1, Roopal B. Thakkar, M.D.1, Ping Jiang, M.S.1, Scott L. Krause,

BSN, B.S.(L&S)1, Michael H. Davidson, M.D., FACC, FACP2, HenryA. Punzi, M.D.3; (1)Abbott, Abbott Park, IL; (2)The University ofChicago Pritzker School of Medicine, Chicago, IL; (3)Texas Woman’sUniversity, Dallas, TX PURPOSE: Proprietary niacin extended-release reduces most pro-atherogenic lipids while increasing anti-atherogenic lipids. Therapywith niacin has been associated with flushing and a transient increasein blood glucose levels, although long-term effects on HbA1c are notusually observed. Both flushing and increases in blood glucose may bemediated via associated pathways. Aspirin has been demonstrated tomitigate flushing during adaptation to niacin extended-release therapy.We evaluated the effects of aspirin on changes in blood glucose inpatients with mixed dyslipidemia treated with niacin extended-release. METHODS: Data are from a double-blind, parallel group, multi-center, placebo-controlled study. Patients were randomized to receiveniacin extended-release (500 mg/day week 1; 1000 mg/day week 2;2000 mg/day weeks 3–6) and either 325 mg/day aspirin (n = 90) orplacebo (n = 90). Both maximum severity of flushing [1- to 10-pointscale] and the mean % change from baseline in fasting blood glucosewere compared between treatment groups using one-way analysis ofvariance. RESULTS: Over the entire 6 weeks of treatment, aspirin reducedmean maximum flushing severity by 33% (3.5 aspirin vs 5.2 placebo;P<0.001). Baseline fasting blood glucose levels were similar for bothgroups (niacin extended-release + aspirin, 109.1 mg/dL, niacinextended-release + placebo, 107.3 mg/dL, P=0.66). Aspirin usereduced the magnitude of the increase in fasting blood glucose by55%. The mean % increases in fasting blood glucose over the 6 weeksof treatment were 5.6 ± 17.7, with aspirin, and 12.5 ± 25.2, withplacebo, P=0.03. CONCLUSION: Among patients with mixed dyslipidemia, aspirineffectively mitigates flushing symptoms during adaptation to niacinextended-release therapy. Treatment with aspirin may also reduce themagnitude of the increase in fasting blood glucose associated withniacin extended-release therapy. Published in Journal of Clinical Lipidology 2010;4:213–214

26E. Aliskiren/Valsartan combination is more effective thanvalsartan monotherapy in dipper and non-dipper hypertensivepatients. Thomas D. Giles, M.D.1, Thomas Alessi, M.D.2, DasPurkayastha, Ph.D.2, Dion H. Zappe, Ph.D.2; (1)Tulane UniversitySchool of Medicine, New Orleans, LA; (2)Novartis PharmaceuticalsCorporation, East Hanover, NJ PURPOSE: A “non-dipping”circadian BP pattern is a significantmarker of CV risk. Since renin-angiotensin system (RAS) activation ishigher at night time; we compared the efficacy of combination directrenin inhibitor, aliskiren + angiotensin receptor blocker, valsartan(A/V) 300/320 mg with V 320 mg as assessed by ABPM in bothdipper (D, nocturnal BP fall of at least 10%); and non-dipper (ND, lessthan 10% nocturnal BP fall) hypertensive patients (pts). METHODS: This was a pooled analysis of ABPM data measuredover 24h at baseline and week 8 (Spacelabs 90207 device) from 2clinical trials with A/V and V treatment arms, in pts with mean age54.6 yr, BMI 30.6 kg/m2, mean clinic BP 157.2/97.4 mmHg and meanABP 144.0/91.1 mmHg. Eligible pts in study 1 were those withmsDBP 95−109 mmHg and 8-h daytime ADBP ≥90 mmHg and instudy 2 with msSBP ≥160 to <180 mmHg. In both studies, ptsreceived A/V 150/160 mgÆA/V 300/320 mg and V 160 mgÆV 320mg. For this pooled analysis, A/V (70D; 60 ND) was compared with V(68D; 72 ND) respectively. Statistical analyses were based onANCOVA model. RESULTS: At baseline mean ABP profiles were similar in A/V and Vwithin D and ND. ND had higher baseline ABP at night-time than D.At week 8 in D, A/V provided significantly greater reduction frombaseline in mean 24-h ASBP, and daytime ASBP than V. In ND,significant ASBP reduction in favor of A/V in mean 24-h; daytime andnighttime was observed; the reductions were almost twice than that ofV. Similar results were observed for ADBP. CONCLUSION: Addition of aliskiren to valsartan resulted in arestoration of nighttime BP in NDs to a similar level as Ds suggestinga more effective inhibition of RAS in non-dipper hypertensivepatients. Presented at Inter American Society of Hypertension (IASH) 2011,


Orlando, Florida, September 19-24 (Pending acceptance from IASH)

27. Left-ventricular assist device implantation does not alter thepharmacodynamic response to warfarin. Douglas L. Jennings,Pharm.D., BCPS, (AQ-CV), Celeste Williams, M.D., Robert Brewer,M.D.; Henry Ford Hospital, Detroit, MI PURPOSE: Left-ventricular assist devices (LVAD) represent a life-saving modality in patients with advanced heart failure (HF). LVADimplantation necessitates long-term anticoagulation with warfarin toprevent device thrombosis. Patients with HF tend to require lowerdoses of warfarin due an altered pharmacodynamic response. It isunclear if this altered response persists in HF patients after LVADimplantation. The purpose of the present study is to describe the effectof LVAD implantation on the pharmacodynamic response to warfarinin patients with advanced HF. METHODS: All patients with LVAD implantation at our institutionbetween January 1st, 2008 and May 1st, 2010 were screened forinclusion. Patients were excluded if they were not taking warfarinprior to implantation or if they were started on an interacting (i.e.,amiodarone) at the time of implantation. Data collection includeddemographics, INR measurements, and warfarin dosages. The primaryendpoint is the difference in mean weekly warfarin dosage required tomaintain a therapeutic INR (2-3) before and after LVAD implantation.Warfarin requirements pre- and post-implant were determined by theweekly dosage that that produced at least two consecutive therapeuticINR measurements. RESULTS: Of 50 patients who were screened, 14 met inclusioncriteria (53±11.9 years, 86% male, 57% Caucasian, 71% bridge totransplant). All patients received a continuous flow LVAD. The meanweekly warfarin dosage required to maintain a therapeutic INR weresimilar pre- and post-LVAD implantation, 38.5 mg/week versus 36.7mg/week (p=0.26). Five patients required a lower dose of warfarin,while three patients required slightly higher doses of warfarin.Furthermore, there was no difference in warfarin dosage requirementsbetween the bridge to transplant (p=0.28) and the destination therapy(p=0.75) patients. CONCLUSIONS: This project indicates that LVAD implantation maynot have a significant impact on the pharmacodynamic response ofwarfarin in patients with advanced HF.

28. Lack of significance between use of statins and cardiovascularevents in carriers of the Kinesin Family Member 6 Gene719Arginine Allele. Randall P. Sharp, Pharm.D., BCPS1, Lisa A.Appeddu, Ph.D.2, Akm Islam, M.B.B.S.3, Riaz Sirajuddin, M.D.3;(1)Southwestern Oklahoma State University College of Pharmacy,Weatherford, OK; (2)Southwestern Oklahoma State University Schoolof Health Sciences, Weatherford, OK; (3)Heart Solutions ofOklahoma, Oklahoma City, OK Prior genetic studies have shown increased cardiovascular events(CV) in carriers of the KIF6 719Arginine allele (KIF6 positive), aswell as significant reduction in CV events in carriers treated withHMG-CoA reductase inhibitors (statins). However, this iscontroversial since recent published studies have shown a lack ofsignificant difference in CV event reduction between KIF6 positiveversus KIF6 negative patients treated with statin drugs. PURPOSE: To investigate whether a significant difference existsbetween KIF6 positive versus KIF6 negative patients taking statindrugs and having a history of CV events. METHODS: Laboratory data was collected in a private cardiologist’sclinic over a one year period on 110 patients. Data was then analyzedretrospectively using the Pearson c2 test. In addition to KIF6 allelestatus, other included parameters were patient sex, previous history ofCV events, body mass index (BMI), and whether or not a patient hadever taken a statin. RESULTS: The population was 64.5% female and 35.5% male(average age= 61.2 years). Approximately 33% had a history of atleast one CV event, defined as myocardial infarction, percutaneouscoronary intervention, coronary artery bypass grafting, stroke, ortransient ischemic attack. Approximately 64% of patients were KIF6positive, which is not different (P=0.44) from previously publishedpopulation estimates (60%). No difference was found in CV eventsbetween the proportion of KIF6 positive and KIF6 negative patientswho had never taken a statin (P=0.42), or had taken a statin (P=0.82).

The results remained non-significant (P>0.05) even when patient sexand BMI were considered. CONCLUSION: The results are similar to recent studies which haveshown no significant difference in cardiovascular event reduction inKIF6 positive versus KIF6 negative patients taking statin drugs. Usingstatins to reduce cardiovascular events based on patients’ KIF6 allelestatus remains inconclusive, and requires further investigation.

29. The impact of a clinical pharmacist on a cardiovascularsurrogate endpoint: A pilot study. Toni L. Ripley, Pharm.D.1, DonaldL. Harrison, Ph.D.1, Tiffany Sanders, Pharm.D., Student1, Thomas A.Hennebry, M.D.2, R. Chris Rathbun, Pharm.D.1; (1)University ofOklahoma College of Pharmacy, Oklahoma City, OK; (2)University ofOklahoma Health Sciences Center, Department of Medicine,Oklahoma City, OK PURPOSE: A pharmacist-managed cardiovascular clinic wasinitiated in a faculty-based adult cardiology clinic in 2/2009. Patientsare referred by cardiologists for cardiovascular disease (CVD)pharmacotherapy management. No data currently exist comparingcardiologist plus clinical pharmacist to cardiologist management alonewhen the pharmacist’s scope of practice is broad and patient caredecisions are independent of a protocol or physician consultation. Thisreport evaluated the impact of a clinical pharmacist on one CVDsurrogate marker. METHODS: A retrospective, matched-cohort, pilot study comparingpatients managed by cardiologists alone versus cardiologist plus aclinical pharmacist was conducted. Patients with hypertension and atleast two blood pressure (BP) results ≥3 months apart between2/1/2009 – 4/30/2011 were included. Age- and disease-matchedpatients not referred to the pharmacist were consecutively identifiedfrom five internal cardiologists to serve as controls (3:1 match). BPresults proximal to the beginning and end dates of the study periodwere compared. RESULTS: Patients in the pharmacist intervention group (n=57) weremore likely to have heart failure (48.5% vs. 13.6%, p<0.001) and takemore anti-hypertensives (3.5 vs. 2.6, p<0.001) compared to thecardiologist control (n=155); other characteristics were similarbetween groups. The number of patients with Stage-2 hypertensionwas significantly reduced in the intervention group (p=0.02), but notin controls (p=0.73). Diastolic BP was reduced by 2.6mmHg in theintervention group (p=0.05); systolic BP reductions did not achievestatistical significance (4.3mmHg, p=0.16). Conversely, non-significant increases in both systolic and diastolic BP (1.0/0.3mmHg,respectively) were observed in the controls. CONCLUSION: BP improvements occurred with clinical pharmacistmanagement, but not with cardiologist management alone. While priorliterature shows BP improvement in pharmacist specialty managementclinics (e.g., hypertension clinic), this is the first report documentingthe benefit of a clinical pharmacist on one established surrogatemarker while managing diverse CVD compared to usual cardiologistcare.

30. Description of antihypertensive use in patients with resistanthypertension prescribed four or more agents. Michele R. Hanselin,Pharm.D., Joseph J. Saseen, Pharm.D., Richard R. Allen, M.S., JoelC. Marrs, Pharm.D., BCPS, Kavita V. Nair, Ph.D.; University ofColorado School of Pharmacy, Aurora, CO PURPOSE: American Heart Association (AHA) recommendedtreatment for resistant hypertension includes maximizing diuretictherapy (e.g., chlorthalidone as the preferred thiazide, adding analdosterone antagonist) and using effective antihypertensivecombinations. The purpose of this study was to describe the use ofantihypertensives in patients with resistant hypertension prescribedfour or more agents. METHODS: This retrospective cohort study evaluated adults withresistant hypertension defined as concurrent use of four or moreantihypertensive agents. The Medstat Marketscan Claims Databases,representing over 100 employers, were used to identify patients withresistant hypertension based on ICD-9 and National Drug Codesbetween May 1, 2008 and June 30, 2009. The primary objective wasto describe the use of antihypertensive agents in this population, andthe secondary objective was to assess whether prescribing reflectsAHA recommendations.

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RESULTS: A total of 140,263 patients met study criteria. The meanage was 63.8 years. Patients were most frequently prescribed anangiotensin converting enzyme inhibitor (ACEi) or angiotensinreceptor blocker (ARB) (96.2%), diuretic (93.2%), calcium channelblocker (83.5%), and/or beta-blocker (80.0%). Only 3.0% and 5.9% ofpatients were prescribed chlorthalidone or an aldosterone antagonist,respectively. A fixed-dose combination product was used in 63.2% ofpatients and 10.1% were on at least two different fixed-dosecombination products. A total of 5.7% of patients were on two agentsfrom the same drug class and 15.6% were prescribed the combinationof an ACEi with ARB. CONCLUSION: First-line antihypertensives recommended byevidence-based guidelines were the most frequently prescribed agentsin this resistant hypertension population. However, controversialtreatments (i.e., ACEi with ARB, combination of two agents from thesame drug class) were prescribed more often than AHA recommendedtreatments for resistant hypertension. These data demonstrate that useof chlorthalidone and aldosterone antagonists are underprescribed inpatients with resistant hypertension.

31. Does Magnesium L-Lactate Improve Quality of Life inPatients with an Implantable Cardioverter Defibrillator?William L. Baker Jr., Pharm.D.1, Jeffrey Kluger, M.D.2, C. MichaelWhite, Pharm.D., FCCP, FCP3, Krista D. Riche, Pharm.D., BCPS4,Craig I. Coleman, Pharm.D.3; (1)University of Connecticut School ofPharmacy, Farmington, CT; (2)Hartford Hospital, Hartford, CT;(3)University of Connecticut, Hartford, CT; (4)Mississippi BaptistMedical Center, Jackson, MS PURPOSE: The objective of this prespecified substudy of theAdjuvant Magnesium Trial was to evaluate the impact of oralmagnesium l-lactate on quality of life (QoL) in patients with animplantable cardioverter defibrillator (ICD). METHODS: In this prospective, double-blind, placebo-controlledtrial, 70 patients with an ICD were randomized to receive oralmagnesium l-lactate (n=35) (6 tablets supplying a total of 504mgelemental magnesium daily) or matching placebo (n=35). Quality oflife was measured using self-administered Ferrans & Powers QoLIndex (Cardiac Version) questionnaires at baseline and at 3 and 6months of therapy. This tool assesses QoL in persons with heartdisease including satisfaction and health perception, functioning,socioeconomic factors, psychological and spiritual well-being, andfamily life. Participants rated their satisfaction over 35 questions withchoices from 1 (“very dissatisfied”) to 6 (“very satisfied”). Totalscores ranged from 0 to 30 points with higher scores indicating betterQoL. Changes from baseline were compared between groups with theMann-Whitney U or Student t-test (SPSS version 17.0, Chicago, IL). RESULTS: No significant differences in baseline characteristics, totalQoL score or subscale QoL scores were seen. Due to the large numberof tablets needed per day, long-term adherence was poor. Overall, 45(64%) and 30 (43%) randomized patients completed questionnaires at3 and six months. Magnesium l-lactate did not significantly impact thechange from baseline in overall or subscale QoL scores versus placeboat 3 months. At 6 months, magnesium l-lactate did not significantlyimpact the change from baseline in overall QoL scores butsignificantly improved the health/functioning subscale score versusplacebo (1.04 vs. -1.22, p=0.04). CONCLUSION: Overall, high dose magnesium l-lactate therapydoes not appear to appreciably impact QoL in patients with an ICDover a 6-month period.

32E. Cardiac events, infections and bleeds contribute to highervascular and non-vascular mortality with clopidogrel compared toticagrelor treatment in patients undergoing coronary arterybypass grafting. Christoph MH Varenhorst, M.D., Ph.D.1, UlricaAlström, M.D.2, Benjamin M. Scirica, M.D., M.P.H.3, Charles W.Hogue, M.D.4, Nils Åsenblad, PhLic, M.S.1, Jay Horrow, M.D., M.S.5,Gunnar Brandrup-Wognsen, M.D., Ph.D.6, Lars Wallentin, M.D.,Ph.D.1, Claes Held, M.D., Ph.D.1; (1)Uppsala Clinical ResearchCenter, Uppsala, Sweden; (2)Uppsala University, Uppsala, Sweden;(3)TIMI Study Group / Brigham and Women’s Hospital, Boston, MA;(4)The Johns Hopkins University School of Medicine, Baltimore,MD; (5)AstraZeneca, Wilmington, DE; (6)AstraZeneca, Mölndal,Sweden

PURPOSE: In the PLATO (Platelet Inhibition and Patient Outcomes)trial, patients assigned to ticagrelor as compared to clopidogrelundergoing coronary artery bypass graft surgery (CABG) had areduction in total and cardiovascular mortality. This study furtherinvestigated the differences in causes of post-CABG deaths. METHODS: In the 1261 patients with CABG within 7 days afterstopping study drug, adjudicators blinded to treatment classified post-CABG deaths into subcategories of causes of vascular and non-vascular deaths, and identified bleedings and infections contributingto, although not necessarily directly causing the fatality. RESULTS: Numerically fewer vascular deaths from myocardialinfarction, heart failure, sudden death/arrhythmia and hemorrhagicstroke/bleeding occurred in the ticagrelor compared to the clopidogrelgroup. Among nonvascular deaths, infection was a less common causeof death with ticagrelor than clopidogrel, as were both bleeding andinfection as contributing causes. CONCLUSIONS: Myocardial infarction, heart failure, sudden deathand infections constituted the majority of post-CABG causes of death.Mortality was lower with ticagrelor due to fewer cardiac events,infections and bleedings than with clopidogrel.

Ticagrelor Clopidogrel(n=632) (n=629)

Primary cause of death (n=1261) (%) (%) Total vascular death 25 (4.0) 47 (7.5) Acute myocardial infarction 10 (1.6) 14 (2.2) Heart failure 6 (0.9) 9 (1.4) Arrhythmia/Sudden death 3 (0.5) 9 (1.4) Ischemic stroke 1 (0.2) 1 (0.2) Hemorrhagic stroke/Intracranial

hemorrhage 0 (0) 3 (0.5) Bleeding/Other hemorrhage 2 (0.3) 4 (0.6) Other vascular death 3 (0.5) 7 (1.1) Total non-vascular death 4 (0.6) 11 (1.7) Infection 2 (0.3) 8 (1.3) Gastrointestinal (not bleeding),

MODS (Multiple Organ

Dysfunction Syndrome) 2 (0.3) 2 (0.3) Suicide 0 (0) 1 (0.2) Infection contributed, but did not

directly cause death (all deaths) 4 (0.6) 8 (1.3) Bleeding contributed, but did not

directly cause death (all deaths) 7 (1.1) 20 (3.2)Presented at Data will be presented at the European Society ofCardiology congress, Paris, France, Aug 17–31

33. Meta-analysis of the relationship between aspirin dosing andefficacy and bleeding outcomes in medically managed patientswith acute coronary syndromes (ACS). Jeffery S. Berger, M.D.,M.S., FACC, FAHA1, Rachel H. Sallum, B.S., BA2, Brian G. Katona,Pharm.D.3, Juan Maya, M.D., M.S.3, Gayatri Ranganathan, M.S.2,Mkaya Mwamburi, M.D., Ph.D.4; (1)New York University MedicalCenter, New York, NY; (2)United BioSource Corporation, Lexington,MA; (3)AstraZeneca LP, Wilmington, DE; (4)Tufts University Schoolof Medicine, Boston, MA PURPOSE: Acetylsalicylic acid (ASA) dosing guidelines for ACStreatment are inconsistent and lack supporting data. This analysisevaluated the relationship between ASA maintenance dosing andclinical outcomes in patients with ACS who did not undergorevascularization and are managed medically. METHODS: A meta-analysis was conducted with random-effectsmodeling to estimate the frequency of clinical outcomes for low(75–149 mg) and high (150–325 mg) doses of ASA, using data fromworldwide clinical and observational trials published from Jan 1995 toFeb 2010, available from PubMed, EMBASE and Current Contents.Clinical outcomes measured were: revascularization rate (overall rate,percutaneous coronary intervention [PCI] or coronary artery bypassgraft [CABG]), cardiovascular (CV) death, all-cause death,myocardial infarction (MI), stroke, and bleeding at 1, 3, 6 and 12months. RESULTS: Sixty-eight studies including 207,523 patients wereaccepted and appraised for quality using Oxford Centre for Evidence-Based Medicine scoring. Significant heterogeneity was seen in theresults (quantified using the Cochran’s Q statistics and the I2


measures), due to differences in enrolment procedures, medicalmanagement regimens and timing of administration, study designs andsome inconsistencies in the definitions of bleeding and MACE. At onemonth, the incidence of clinical outcomes with high- and low-doseASA groups were 4.9% and 5.0% for MI; 6.3% and 3.7% forrevascularization; 1.4% and 1.3% for stroke; 5.5% and 3.4% for CVdeath; 5.7% and 4.3% for all cause death; and 4.0% and 1.7% formajor bleeding, respectively. Meta regression demonstrated asignificant association between aspirin dose and major bleeding(p=0.037). Further data will be presented at the meeting. CONCLUSIONS: This analysis suggests that in patients receivingmedical management for ACS, major bleeding occurred morefrequently in patients who received higher doses of ASA. ASA dosedoes not have a statistically significant impact on the other outcomesanalyzed.

34. Comparative Effectiveness of Endothelin Receptor Antagonistsfor the Treatment of Pulmonary Arterial Hypertension (A PilotStudy). Heather A. Wong, Pharm.D, Shirley Yan, B.S., Dana P.McGlothlin, M.D., Jaekyu Shin, Pharm.D.; University of California,San Francisco, San Francisco, CA PURPOSE: Bosentan and ambrisentan are two endothelin receptorantagonists (ERA) used to treat pulmonary arterial hypertension(PAH). Because their comparative effectiveness is unknown, wecompared changes in 1) pulmonary arterial systolic pressure (PASP),2) New York Heart Association (NYHA) functional class and 3)severity of tricuspid regurgitation (TR) in patients with PAH whoreceived either bosentan or ambrisentan for at least 3 months. METHODS: Adult PAH patients who initiated either bosentan orambrisentan in the UCSF Medical Center between January 1, 2008and December 30, 2010 and continued an ERA for at least 3 monthswere identified by chart review. Patients were excluded ifechocardiography and NYHA functional class data were not available6 months before and 3 months after an ERA treatment. Primaryoutcome was the change in PASP and secondary outcomes were thechanges in NYHA functional class and severity of TR before and afteran ERA treatment. PASP and severity of TR were measured byechocardiography. The Wilcoxon Rank Sum test was used to comparethe outcomes between the groups. RESULTS: Sixteen patients were eligible for the study. Pre-treatmentand post-treatment characteristics were not significantly differentbetween the bosentan (n=7) and ambrisentan (n=9) groups except thatTR was more severe in the bosentan group. Median change in PASPwas not significantly different between the groups (-2.0 mmHg(interquartile range 14.0) in the bosentan group vs. - 10.0 mmHg (IQR38) in the ambrisentan group; P=0.92). In addition, median changes inNYHA functional class and severity of TR were not significantlydifferent between the groups. CONCLUSION: Our data suggest that bosentan and ambrisentanmay not be different in changing PASP 3–6 months after the initiationin PAH patients. Due to the pilot nature of the study, studies withlarger sample sizes are needed to confirm our findings.

35. Changes in RIFLE criteria after coronary artery bypass graftsurgery in patients with recent exposure to angiotensin convertingenzyme inhibitors and angiotensin receptor blockers. Jennifer L.Neill, Pharm.D.1, Shannon W. Finks, Pharm.D.2, Ronald L. Braden,Pharm.D.1, Kelly C. Rogers, Pharm.D.2; (1)Veterans Affairs MedicalCenter, Memphis, TN; (2)University of Tennessee College ofPharmacy, Memphis, TN PURPOSE: Acute kidney injury (AKI) is a potential complication ofcoronary artery bypass grafting (CABG) and can be identified byRIFLE criteria (Risk, Injury, Failure, Loss, End-stage kidney disease).The role of angiotensin converting enzyme inhibitors (ACEI) andangiotensin receptor blockers (ARB) in AKI after CABG remainsundefined. This study evaluated the use of preoperative ACEI andARB in patients undergoing CABG and their effects on changes inpostoperative RIFLE criteria. METHODS: Medical records of patients undergoing CABG betweenOctober 1, 2007 and October 30, 2010 at the Veteran Affairs MedicalCenter in Memphis, Tennessee were reviewed. Patients who receivedpreoperative (within 24 hours) ACEI or ARB were compared topatients who did not. Patients with estimated glomerular filtration rate

< 15 ml/min/1.73m2, on hemodialysis, or with preoperativecardiogenic shock were excluded. The primary endpoint was a changein baseline renal function classified by RIFLE criteria within 7 days ofthe procedure. RESULTS: A total of 211 patients met inclusion criteria. Of these,67% (n=142) received an ACEI or ARB within 24 hours of CABG and33% (n=69) did not. The following changes in RIFLE criteria wereseen in patients receiving preoperative ACEI or ARB compared tothose who did not, respectively: Risk: 4.9% (n=7) vs 5.8% (n=4);Injury: 2.8% (n=4) vs 0%; Failure: 1.4% (n=2) vs 0%. Loss and endstage kidney disease were not observed. A statistically significantdifference was found between groups in mean postoperative SCr (1.26vs 1.11, p<0.05), mean preoperative K (4.29 vs 4.08, p<0.05), andmean postoperative K (4.57 vs 4.46, p<0.5). No difference in mortalityor mean length of stay was seen. CONCLUSIONS: ACEI or ARB use prior to CABG was notassociated with an increase in AKI, and these agents should not beheld prior to CABG in hopes of preventing AKI.

36. National Cholesterol Education Program (NCEP) Lipid GoalAchievement Beyond Low-density lipoprotein cholesterol (LDL-C)in Patients with Diabetes Mellitus (DM): Focus on Non-HighDensity Lipoprotein Cholesterol (nonHDL-C) in the PracticeInnovation and Cl. Sarah Spinler, Pharm.D.1, Mark J. Cziraky,Pharm.D.2, Paul F. Chan, M.D., M.S.3, Feng-ming Tang, M.S.3,Thomas M. Maddox, MD, MSc4, Tyan Thomas,Pharm.D.1, Gladys G.Duenas, Pharm.D.1, Jennifer A. Reinhold, Pharm.D.1, Vincent J.Willey, Pharm.D.1; (1)Philadelphia College of Pharmacy, University ofthe Sciences, Philadelphia, PA; (2)HealthCore, Inc, Wilmington, DE;(3)St. Luke’s Mid-America Heart Institute, Kansas City, MO;(4)Denver VA Medical Center, Cardiology Section, Denver, CO PURPOSE: To determine rates of attainment of NCEP lipid goals inpatients with DM within NCDR’s cardiology outpatient PINNACLERegistry. METHODS: Patients in PINNACLE from 7/1/2008 to 12/31/10 withDM plus dyslipidemia and at least 1 fasting lipid panel wereidentified. A hierarchical modified Poisson regression model was usedto identify factors associated with attainment of LDL-C (≤ 100mg/dL), nonHDL-C (≤ 130 mg/dL), and both goals. RESULTS: Of 576,787 patients enrolled in PINNACLE, 36,188(6.27%) had a history of dyslipidemia and DM with at least 1 fastinglipid panel. Mean age was 67.5 ± 11.0 yrs, 58.5% were male and82.8% were white. Prevalence rates of co-morbidities were CAD73.6%, MI 23.2%, peripheral arterial disease 16.1%, and stroke/TIA5.8%. Mean LDL-C was 84.6±37.1 mg/dL, HDL-C 43.5±14.0,triglycerides 150.5±92.9 and nonHDL-C 114.7±43.3 mg/dL. LDL-C,nonHDL-C and both goals were achieved by 73.9%, 72.0%, and68.3%, respectively. Older patients were more likely (Risk Ratio per 5yrs 1.04, 95% CI 1.04–1.05), and females less likely (Risk Ratio 0.88,95% CI 0.87–0.90) to achieve nonHDL-C goals. The presence ofatherothrombotic disease did not impact likelihood of achieving eitherLDL-C, nonHDL-C, or both goals. Use of statins, non-statin lipid-lowering agents, and their combination were the best independentpredictors of achieving goals. Compared to the use of statin alone,combination therapy was not associated with a greater likelihood ofachieving nonHDL-C goal (Risk Ratio 1.00, 95% CI 0.98–1.03). CONCLUSION: In a large, outpatient cardiac registry, the majorityof patients with DM were at or below LDL-C and nonHDL-C goalsand more than two-thirds achieved both goals. Predictors of goalattainment were similar. These data suggest current treatment patternsby cardiologists successfully achieve nonHDL-C goals in the majorityof DM patients. Additional research is needed on the role ofcombination therapy for achieving nonHDL-C goals.

37. A Comparison of Management Strategies in Patients withAcute Coronary Syndrome Based on Clopidogrel Use. Paul P.Dobesh, Pharm.D.1, Julie H. Oestreich, Pharm.D., Ph.D.1, Sarah M.Hanigan, Pharm.D.2, Hiedi L. Brink, Pharm.D.1, Sloane M. Schneider,Pharm.D.1, Janelle M. Weber, Pharm.D.1; (1)University of NebraskaMedical Center, Omaha, NE; (2)The Nebraska Medical Center,Omaha, NE PURPOSE: This study documented the management strategies inpatients that present to the emergency department with an acute

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coronary syndrome (ACS) already on clopidogrel versus patients notpresenting on clopidogrel. Patients presenting on clopidogrel arealready taking maximal antiplatelet therapy. It is also documented thatover 30% of patients taking clopidogrel can be classified as“nonresponders” and these patients are at high-risk for adverseoutcomes. Therefore, patients already taking clopidogrel could beclassified as higher-risk patients and may warrant more aggressivetherapy. METHODS: This study was a retrospective review of medicalrecords for all patients presenting to our institution with the primarydiagnosis of ACS between 1/9/2008 to 12/31/2010. Comparisons weremade based on baseline demographics, clinical presentation,interventional procedures, and utilization ofantiplatelet/anticoagulation therapy. RESULTS: We identified 493 patients who met the inclusion criteriafor this study. Of those patients 73 (15%) presented on clopidogrel and420 (85%) were clopidogrel naïve. Patients presenting on clopidogrelwere significantly more likely have a history of hypertension,dyslipidemia, prior myocardial infarction, and prior coronaryrevascularization, yet were less likely to present with STEMI (8% vs.28%; p<0.01). Patients already on clopidogrel were more likely toreceive clopidogrel after admission (89% vs. 60%; p<0.001), but theuse of prasugrel did not differ (5% for both). The use and type ofanticoagulants did not differ between the groups. Patients undergoingpercutaneous coronary intervention already on clopidogrel were lesslikely to receive a 600 mg loading dose of clopidogrel (18% vs. 73%;p<0.001) and a glycoprotein IIb/IIIa inhibitor (50% vs. 74%;p<0.001). CONCLUSION: We did not identify major differences in themanagement strategies used for patients that present with ACS despitetaking clopidogrel. This is probably due to the reduced severity ofACS in these patients. Further analysis of management within ACSclassifications will be conducted.

38. Increasing the efficacy of heparin infusions through computer-calculated weight-based infusions with auto-populated infusiondoses and partial thromboplastin time orders. Lindsay M. Arnold,Pharm.D., Paul Huiras, Pharm.D., BCPS; Boston Medical Center,Boston, MA PURPOSE: This study assessed whether computer-calculated weight-based heparin infusion order sets with auto-populated dosing andpartial thromboplastin time (PTT) orders increased the percentage ofheparin infusions that lead to therapeutic PTT values within 24 hours. METHODS: All patients receiving heparin infusions for greater thansix hours for acute coronary syndrome or venous thromboembolismwere assessed. Patients treated with heparin prior to the revision ofheparin order sets (January 2010 through March 2010) were comparedto post-order set treated patients (January 2011 through March 2011).Primary outcome was the percentage of patients with a therapeuticPTT within 24 hours. Time to therapeutic PTT and the percentage ofsubtherapeutic, therapeutic and supratherapeutic PTT values werecompared. A subgroup analysis was conducted on a random samplingof patients to assess accuracy of weight-based dosing. RESULTS: A therapeutic PTT was achieved in 145 patients in thepost order set group (53.1%) compared to 151 patients (44.9%) in thepre-order set group (p=0.0048). Mean time to therapeutic PTT was17.9 hours in the post-order set group compared to 21.3 hours in thepre-order set group, p=0.01. A larger percentage of PTT values were intherapeutic range in the post order set group (50.5 vs 43.7%,p<0.0001). This difference was driven by a smaller percentage ofsubtherapeutic PTT values in the post order set group (27.8 vs 35.6%,p<0.001). A subgroup analysis revealed a larger percentage of heparininfusions the post-order set group were accurately weight based (96 vs75%, p=0.0488), were accompanied by an initial bolus (68 vs 33.3%,p=0.0277) and adjustment bolus doses (22.2 vs 0%, p =0.0059). CONCLUSION: Computer-calculated weight-based heparin infusionorder sets with auto-populated infusion dosing and partialthromboplastin time (PTT) orders increased the percentage of patientson heparin infusions that obtained a therapeutic PTT within 24 hours.

39. Determinants of Worsening Renal Function with Diuretic DoseEscalation in a Chronic Heart Failure Ambulatory Population.Vicki L. Groo, Pharm.D., Krista M. Williams, Pharm.D., Larisa H.

Cavallari, Pharm.D., Thomas D. Stamos, M.D.; University of Illinoisat Chicago, Chicago, IL PURPOSE: Heart failure (HF) patients often require diuretic (D)escalation to treat signs/symptoms of volume overload. Increasingdoses of D may worsen renal function (WRF). The purpose of thisstudy was to identify patient characteristics that predict (WRF) after Descalation. METHODS: Retrospective chart review of ambulatory HF patientswho had an increase in oral D for volume overload between07/01/2007 and 06/30/2010. For repeat patients, only the firstencounter was recorded. WRF was defined as a rise in serumcreatinine > 0.3 mg/dL after D therapy escalation. Baselinecharacteristics were compared between WRF and stable renal function(SRF) patients. Logistic regression was used to analyze variables withp value of < 0.10. Related hospitalizations were collected for 3months. RESULTS: Eighty-six patients met inclusion criteria of which 30 hadWRF. Demographics, vitals, PMH, HF medications, diuretic regimen,ejection fraction, and BNP were similar between groups. Patients withWRF had a higher baseline BUN (34 + 19 vs 26 + 20 p=0.018) andlower eGFR (48 + 19 vs 59 + 25 ml/min p=0.047). Loop D wasintensified in 75 cases and metolazone was added in 14 (2 patients hadboth interventions). Average time to follow-up labs was 13 + 8 days.Creatinine and BUN rise in WRF versus SRF was 0.63 + 0.44 vs -0.03+ 0.18mg/dl and 19 + 30 vs -0.56 + 10 mg/dl respectively. Of thevariables included in the regression PND (p=0.028, CI 0.13–0.89) andeGFR (p=0.042, CI 0.95–0.099) were predictive of WRF. Relatedhospitalizations were not different between groups. CONCLUSION: Ambulatory heart failure patients requiring D doseescalation are more likely to develop WRF if they are experiencingPND or have more severe renal dysfunction at baseline. WRF did notresult in more hospitalizations.

40E. Influence of Global Region on Outcomes in Large HeartFailure β-Blocker Trials. Mona Fiuzat, Pharm.D.1, ChristopherO’Connor, M.D.1, Karl Swedberg, M.D.2, Michael Caron, Pharm.D.3,Bruce R. Koch II, Pharm.D.3, Peter E. Carson, M.D.4, Wendy A.Gattis-Stough, Pharm.D.5, Gordon Davis, MSPH6, Michael R.Bristow, M.D., Ph.D.7; (1)Duke University Medical Center, Divisionof Clinical Pharmacology, Durham, NC; (2)Sahlgrenska UniversityHospital, Goteborg, Sweden; (3)Gilead, Foster City, CA;(4)Department of Veterans Affairs, Washington, DC; (5)ExpertMedical Communications, Durham, NC; (6)ARCA biopharma, Inc.,Broomfield, CO; (7)University of Colorado Health Sciences Center,Denver, CO PURPOSE: Several HF trials have demonstrated differences inoutcomes by geographic region. We aimed to describe the UnitedStates (U.S.) and the rest of the world (ROW) outcomes from themajor β-blocker heart failure (HF) trials. METHODS: Randomized, double-blind, placebo-controlled studiesthat evaluated β-blockers in HF patients, had a primary endpoint ofmortality, and enrolled U.S. patients were included (MERIT-HF,COPERNICUS, and BEST). CIBIS-II was also included in the pooledanalysis. Cox proportional-hazards regression was used to generate thehazard ratio and the 95% confidence interval (CI) for all-causemortality among the U.S. and ROW subgroups within each trial. Ameta-analysis of the combined mortality rates was performed usingthe Cochran-Mantel-Haenszel statistic, with stratification by study. RESULTS: A total of 8,988 patients were enrolled in the MERIT-HF,COPERNICUS, and BEST studies; 4198 (46.7%) were from the U.S.In the U.S. cohort, the relative risk reduction for each β-blocker wasof smaller magnitude than in the overall cohort and no longersignificant, whereas in the ROW subgroup the mortality benefit for β-blockade persisted. In the pooled analysis (n=11,635), the relative riskof death was reduced by 23% (p<0.001) with β-blockade as comparedto placebo. In contrast, the mortality reduction associated with β-blockade in the U.S. cohort was small and not statistically significant(RR 0.92, 95% CI 0.82–1.02, P=0.117). The survival benefit persistedin the ROW cohort (RR 0.64, 95% CI 0.56–0.72, P<0.001). CONCLUSIONS: Among patients enrolled in the U.S., β-blockadewas associated with a lower magnitude of survival benefit, whereasthe ROW response was similar to the total study population. Thisgeographic difference in treatment response may be a reflection of


population differences, genetics, cultural or social differences indisease management, or low power and statistical chance. Published in Accepted for publication in Journal of the AmericanCollege of Cardiology (JACC) August 23, 2011 issue.

Clinical Administration

41. Impact of pharmacist involvement at discharge on compliancewith The Joint Commission heart failure core measure. HollyHerring, Pharm.D., Toni Ripley, Pharm.D., Kevin Farmer, Ph.D.,Winter Smith, Pharm.D.; The University of Oklahoma College ofPharmacy, Oklahoma City, OK PURPOSE: Pharmacists have been granted authority to documentheart failure (HF) core measures to improve compliance withaccreditation bodies. The optimal role for pharmacists has yet to befully described. This current study sought to explore the potential roleof pharmacist involvement to improve hospital compliance with TheJoint Commission HF core measures. METHODS: A prospective, historical-control study of patientsadmitted to the University of Oklahoma Medical Center with HFduring January–March 2009 (control) and January–March 2010(intervention) was conducted. The primary endpoint was theproportion of patients in compliance with individual components ofthe HF core measure prior to and after pharmacist involvement.Patients were included if they were ≥ 18 years old and had a primarydiagnosis of HF. The pharmacist intervention included assessment andcorrection of the 4 HF core measures if deficiencies were identified. Apost-hoc exploratory analysis assessed the proportion of patients whoreceived pharmacist intervention and the obstacles to pharmacistparticipation. RESULTS: Forty-three charts were screened by the pharmacist; 29patients were excluded due to incorrect admission coding, leaving 14that received pharmacist intervention. No significant changes werefound when the pharmacist was included compared to historicalcontrol (p=0.39). However, the pharmacist was only able to participatein core measure assessment in a small proportion of eligible patients(23.7–63.6% of the individual parameters). Core measures compliancewas high at baseline (93.3–100%) and at follow-up (100%) with allcore measures except discharge instructions (80.6% baseline; 78.9%follow-up). Limited pharmacist availability, after-hours discharging,and lack of notification were identified as obstacles to participation. CONCLUSIONS: No change in HF core measure compliance wasobserved. The lack of improvement may be due to high baselinecompliance or limited patients exposed to pharmacist intervention.Discharge instructions may be the core measure in which futurepharmacist interventions should be targeted.

Community Pharmacy Practice

42. Evaluation of a community pharmacy-based influenzascreening and management program versus pharmacy screeningand referral to standard of care. Michael E. Klepser, Pharm.D.1,Jennifer Hagerman, Pharm.D.2, Donald G. Klepser, Ph.D.3, StephanieA. Klepser, Pharm.D.4, Scott J. Bergman, Pharm.D., BCPS5; (1)FerrisState University, Kalamazoo, MI; (2)Ferris State University, Flint, MI;(3)University of Nebraska Medical Center, Omaha, NE; (4)KCMSPharmacy, Kalamazoo, MI; (5)Southern Illinois UniversityEdwardsville, Springfield, IL PURPOSE: This study assessed the impact of a communitypharmacy-based influenza management program on the time to firstdose of antiviral compared to referral to standard-of-care.Background: Influenza and complications result in 36,000 deaths and226,000 hospitalizations each year in the United States. Vaccination,rapid diagnosis, and early detection of influenza activity are keycomponents for impacting this disease. The first healthcare interactionmany patients with influenza have occurs in community pharmacies. METHODS: This was a prospective, randomized, multi-center studyconducted from October 2009 to May 2010 in 13 communitypharmacies in 4 states. Pharmacists screened individuals 18 years ofage and older who presented with signs/symptoms consistent withinfluenza-like illness (ILI) (onset of cough and fever or body acheswithin the previous 5 days). Pharmacists collected and evaluated vitalsigns (i.e., pulse, blood pressure, respiratory rate, temperature, and

oxygen saturation). On site rapid diagnostic testing for influenza wasperformed and a specimen for viral culture was obtained via throatswab. Patients with ILI, regardless of rapid diagnostic test results,were randomized to initiate treatment with oseltamivir in thepharmacy (treatment group) or referred to their prescriber (referralgroup). Telephone follow-ups were conducted with patients 1, 2, 7,and 14 days following enrollment. RESULTS: Twenty-seven patients were enrolled. Five had riskfactors placing them at high-risk for complications and were referredto their caregivers. Of the remaining 22 patients, 12 were randomizedinto the treatment group and 10 into the referral group. The mean (SD)time to the first dose of oseltamivir was 1hr (0.7hr) and 6.4hr (7hr) inthe treatment and referral groups, respectively (p=0.04). Nodifferences in patient outcomes were noted. CONCLUSION: A community pharmacy-based influenzamanagement program significantly reduces the time to first dose ofantiviral among individuals with ILI compared to those referred toprescribers.

43. Pharmacists and pharmacy students knowledge and attitudesregarding patients with disabilities in Qatar. Sara Al-Dahir,Pharm.D., BCPS1, Barbara Hong, Ph.D.2, Rihab Kaissi, B.S.3, AmaalGulied, B.S.3; (1)Xavier University of Louisiana, New Orleans, LA;(2)Pennsylvania State University, Altoona, PA; (3)Qatar University,Doha, Qatar PURPOSE: This study was conducted to evaluate communitypharmacists and pharmacy student’s knowledge and attitudesregarding patients with disabilities in Qatar. METHODS: This cross-sectional, observational study was conductedamong pharmacy students and pharmacists in Doha, Qatar betweenFebruary and May 2011. This mixed-methods study consisted of asurvey which encompassed demographics, a truncated LEEDSAttitude Towards Concordance Scale, Attitudes Toward Patients withDisabilities Scale and a Social Distance Scale. Two follow-up focusgroups were conducted to extrapolate on results. Descriptive statisticalanalyses and group comparisons were carried out using correlationstatistics and linear regression analysis. Bivariate correlation was usedto determine any association between dependent and independentvariables identified a priori. Predictor factors were determined usinglinear regression and Anova test. RESULTS: A total of 107 (30%, N=362) participants responded tothe survey, resulting in a confidence level of 95% (8% confidenceinterval). The first survey of its type in Qatar, a Cronbach’s Alphascore equal to 0.826 was found for reliability. The majority ofparticipants (35%; n = 35) reported more than 10 years experience and32% (n = 33) interact with patients with disabilities on a monthlybasis. Whereas scores related to concordance were high (Likert Scalescore > 3.5), community pharmacists and pharmacy students werefound to have relatively neutral (Likert score of 2.6-3.4) score ofattitudes toward patients with disability and social distance.Professionalism, attitudes toward patients with disability, and socialdistance were significantly impacted by years of practice (P=0.010),education (P=0.05) and self reported experience with patients withdisabilities (P=0.011), respectively. CONCLUSION: Results suggest that pharmacy students andpharmacists have inconsistent attitudes toward patient care whendiscussing patients with disabilities versus patients withoutdisabilities. Qualitative findings support the need for increasededucation and professional development regarding patients withdisabilities.

44. Smoking cessation counseling in the State of Qatar:community pharmacists’ attitudes and practices. Maguy S. El Hajj,Pharm.D., Reem R. Al Nakeeb, BSPharm, candidate, Rajaa A. AlQudah, BSPharm, candidate; Qatar University College of Pharmacy,Doha, Qatar PURPOSE: Smoking is a major public health problem in Qatar.Community pharmacists are uniquely situated to offer smokingcessation counseling. The study objectives were to determine thesmoking cessation practices of community pharmacists in Qatar, toassess their attitudes about providing smoking cessation counselingand to determine their perceived barriers for pharmacist-providedsmoking cessation counseling

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METHODS: The study objectives were addressed in a cross sectionalsurvey of community pharmacists in Qatar. The survey was designedbased on surveys done in Canada, and other countries. A phone callwas made to all community pharmacists in Qatar requesting theirparticipation. Consenting pharmacists anonymously completed thesurvey either online or as paper based using fax. Data wasdescriptively analyzed using Statistical Package of Social Sciencesversion 18. RESULTS: Over 5 months, we collected 127 surveys (40% responserate). Only 20% of respondents reported that they always or most ofthe time asked their patients if they smoke. Advising quitting andassessing readiness to quit were always or most of the time performedby 66% and 52% of respondents respectively. Use of nicotinereplacement therapy was always or most of the time suggested by 66%of respondents. Only 15% always or most of the time arranged follow-up with smokers and 22% always or most of the time made smokingcessation referrals. At least 80% believed that smoking cessationcounseling was an important activity for pharmacists and was anefficient use of their time. The top two perceived barriers for smokingcessation counseling were lack of time (65% of respondents) and lackof patients’ interest in discussing smoking cessation (54%). CONCLUSION: Qatar community pharmacists have good attitudestoward smoking cessation counseling. These attitudes need to betranslated into action. Interventions should be implemented toovercome perceived barriers and to improve smoking cessationactivities among pharmacists.

Critical Care

45. Comparison of short-term pulmonary improvement associatedwith inhaled nitric oxide and inhaled epoprostenol for acuterespiratory distress syndrome. Bridget A. Scoville, Pharm.D., PaulTan, Pharm.D., Donald W. Johnson, Pharm.D., Patrick Aaronson,Pharm.D.; Shands Jacksonville Medical Center, Jacksonville, FL PURPOSE: The study evaluated the degree of pulmonaryimprovement in patients with acute respiratory distress syndrome(ARDS) before and after an inhaled vasodilator protocol wasimplemented. METHODS: Patients were included if they had a primary orsecondary diagnosis of ARDS, mechanically ventilated, and treatedwith inhaled nitric oxide (iNO) between February 2007 and July 2008or inhaled epoprostenol(iEPO) between February 2009 and July 2010.The percentage improvement in response was recorded for thefollowing oxygenation measurements on days 0-3: SaO2, PaO2, FiO2,PEEP, and PaO2:FiO2 ratio. RESULTS: There were no differences in baseline characteristics suchas age, gender, incidence of vasopressors, and organ dysfunction.When looking at PaO2, FiO2, PEEP, and SaO2 on days 0-3, therewere no differences between the two groups except for in twoinstances. There was a difference in PaO2 between the iNO group(mean change 82.9%) and the iEPO group (mean change 93.1%) onday one (p=0.031) as well as a difference in FiO2 in the iNO group(mean change 0.38%) and the iEPO group (mean change 11.6%) onday zero (p=0.021). CONCLUSIONS: The significant effects on PaO2 on day one andFiO2 on day zero were most likely due to the properties of iNO. iNOworks the most effectively within the first 24 hours of initiation and asa patient continues on iNO the body will become tolerant to theeffects. iEPO worked better on day one at increasing PaO2 most likelybecause there was tolerance built up to the iNO. Overall this studyshows that iNO and iEPO seem to be reasonable options in terms ofshort-term pulmonary improvement.

46. Medication errors and associated factors in the intensive careunit Jimma University specialized hospital in Ethiopia, April,2011. Asrat Agalu, B.Pharm, M.S.; Wollo University, Dessie Ethiopia,Jimma, Ethiopia PURPOSE: To assess medication errors and associated factors duringprescribing and administration of medications in the intensive careunit (ICU) of Jimma university specialized hospital (JUSH) fromFebruary 7–April 15, 2011. METHODS: Prospective cross-sectional study was conducted in theICU of JUSH from February 7–April 15, 2011. All physician and

nurse interventions to all patients admitted to the ICU during the studyperiod were included in the study. All physicians and nurses whoprescribed and administered medications were also included. Datawere collected by direct observation, self administered questionnaire,in-depth interview, review of medication documentation charts andpatient cards. Data was edited, coded, entered to SPSS windowsversion 16.0 and finally cleaned. Descriptive statistics and chi-squaretest was used. RESULTS: Frequency of prescribing and administration MEs in theICU of JUSH was 209 (52.5%) and 621 (51.8%), respectively.Common prescribing errors were wrong combination (25.7%), wrongfrequency (15.5%) and wrong dose (15.1%), while administrationerrors were wrong timing (30.3%), omission due to unavailability(29.0%) and missed doses (18.3%). MEs associated with antibioticstook the lion’s share in both medication prescribing (32.5%) andadministration (36.7%) errors. Errors related to cardiovascular drugs,analgesic/antipyretics and anticonvulsants were also common in bothcases. Among the factors that contributed to medication errorscomplexity of regimen (p=0.015), time of drug administration(p=0.000), and type of diagnosis for which medications were indicated(p=0.017) among others. CONCLUSION: MEs at the prescribing and administration phaseswere frequent in the ICU of JUSH and the causes were multifactorial.Error reporting systems, awareness creation among health careprofessionals, and inclusion of clinical pharmacists as member ofhospital health care team in general and ICU in particular mightreduce MEs and its aftermath.

47E. Severity and preventability of drug-induced hypotension.Sandra L. Kane-Gill, Pharm.D., MSc1, Jaclyn M. LeBlanc, Pharm.D.2,Joseph Dasta, M.Sc.3, Critical Care Pharmacotherapy Trials Network,Pharm.D.1; (1)University of Pittsburgh School of Pharmacy,Pittsburgh, PA; (2)Atlantic Health Sciences Corporation, Saint John,NB; (3)The University of Texas College of Pharmacy, Austin, TX PURPOSE: While hypotension is common in critically ill patients,the incidence of drug-induced hypotensive events has not beenreported. The purpose of this study is to evaluate the incidence ofdrug-induced hypotension in the ICU. By identifying hypotension as adrug-related hazardous condition, prevention strategies could bedeveloped to minimize hypotention-related injury. METHODS: In this observational study, clinical pharmacists in 53ICUs from 23 hospitals recorded episodes of hypotension during a 24-hour period. Hypotension was defined as SBP < 90 mm Hg or adecrease in SBP of 30 mm Hg over two hours in a previously non-hypotensive patient. Each hypotensive episode was assessed for thedegree of a drug-related cause using the Kramer algorithm. Eachepisode of drug-induced hypotension was further evaluated whether itwas due to a medication error. RESULTS: Of the 690 patients evaluated, 238 (34.5%) experienced atleast one episode of drug-induced hypotension. SBP < 90 mmHgoccurred in 42% of episodes and 55% were from a decrease in SBP of30 mm Hg over two hours. Fifty six percent of episodes were possiblyrelated to a drug, and 10.2% were considered probable or definite. Themost common identified drugs were beta-blockers, narcotics,propofol, furosemide, benzodiazepines and hydralazine. 36.4%resulted from a medication error of which 4.3% reached the patientresulted in no harm, 3.5% caused no harm but required monitoring orintervention to prevent harm, 3.5% may have resulted in harm, and0.3% may have contributed to patient’s death in 0.3%. The mostcommon error types were improper dose (54%), wrong time (19%),and prescribing (16%). Approximately 75% of patient requiredintervention for this episode of hypotension including crystalloids,norepinepherine, colloids, dopamine and phenylepherine. CONCLUSION: Drug-induced hypotension occurs in one-third ofICU patients, often requires active intervention and can result in harm.One-third of drug-induced hypotensive events are preventable. Published in Crit Care Med 2010;38 (suppl): 580.

48. Pharmacist publications in critical care literature over aperiod of ten years. Christopher A. Paciullo, Pharm.D.1, CatherineKim, Pharm.D., Student2, Yannolis Hernandez, Pharm.D., Student3,Sandra L. Kane-Gill, Pharm.D., M.S., FCCM, FCCP4; (1)EmoryUniversity Hospital, Atlanta, GA; (2)University Of Pittsburgh School


of Pharmacy, Pittsburgh, PA; (3)Mercer University College ofPharmacy and Health Sciences, Atlanta, GA; (4)University ofPittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: The number of pharmacists caring for critically illpatients have increased through the years but their contributions toscholarly work in critical care is unknown. This evaluation analyzedthe impact of pharmacists in critical care literature over a period of tenyears. METHODS: A search of Critical Care Medicine (CCM) andIntensive Care Medicine (ICM) was conducted for the calendar years1999, 2004 and 2009 and classified into one of two categories—“Pharmacist publication” or “Non-pharmacist publication.” Criteriafor “Pharmacist publication” were at least one of the authors having acredential of B.Pharm., Pharm.D., R.Ph. or having a primaryaffiliation with a college or department of pharmacy. Pharmacistpublications were further analyzed to determine the scope and role ofthe pharmacist. RESULTS: 3265 manuscripts were evaluated for inclusion. In 1999,2004 and 2009 pharmacists participated in 3.79% (n=31), 2.2% (n=24)and 3.6% (n=37) of all publications screened, respectively. Of these,pharmacists were first authors in 16 (1999), 7 (2004), and 19 (2009)publications. The majority of these publications were authored by amultidisciplinary group, with publications written only by pharmacistsaccounting for 14% (n=5), 13% (n=3) and 5% (n=2) of all pharmacistpublications in 1999, 2004 and 2009, respectively. The number ofprospective studies involving pharmacists decreased over time (19 in1999, 14 in 2004 and 8 in 2009). All of the pharmacist publicationsevaluated were written on disease states, patient safety,pharmacoeconomics or pharmacotherapy. CONCLUSION: Positively, there appears to be multidisciplinarycollaboration on pharmacist-authored publications. However,manuscripts written by pharmacists are poorly represented withincritical care literature and the rate of publications has not increasedover time. Potential explanations could be a preference forpharmacists to publish in pharmacy-specific journals, pharmacistshave a high clinical demand and little time for scholarship orpharmacists have limited research training.

49. Continuous neuromuscular blockade and train-of-fourmonitoring in patients treated with therapeutic hypothermia.James M. Hollands, Pharm.D., Mollie Gowan, Pharm.D.; Barnes-Jewish Hospital, Saint Louis, MO PURPOSE: Although therapeutic hypothermia is being usedincreasingly for the management of post-cardiac arrest patients, theassociated pharmacokinetic and pharmacodynamic changes are notwell understood for medications, including neuromuscular blockingagents (NMBA). This study is an evaluation of resolution ofneuromuscular function in patients receiving a continuous infusion ofNMBA during hypothermia. METHODS: Twenty-six post-cardiac arrest patients managed withtherapeutic hypothermia were included in this study. The primaryendpoint was time to return of neuromuscular function, defined asreturn to 4/4 twitches on train-of-four (TOF) monitoring. Otheroutcomes included hospital and ICU length of stay, duration ofmechanical ventilation, return of neurologic function based onGlascow coma scale, and adverse events. RESULTS: Median time to recovery of neuromuscular function wasseven hours, ranging from one to 36 hours. The duration of NMBAinfusion and the total dose received varied across the patientpopulation. In univariable analysis, creatinine clearance wassignificantly higher in patients who recovered neuromuscular function≤6 hours compared to >6 hours, though this did not remainstatistically significant in multivariate analysis. At baseline, patientswith delayed recovery were older with more comorbidities, althoughthese differences were not significant. A total of eight patients (30%)survived to hospital discharge, all exhibiting an improvement inneurologic function. Hospital and ICU lengths-of-stay and duration ofmechanical ventilation were not significantly longer in patients whorecovered neuromuscular function >6 hours compared to ≤6 hours, norin survivors compared to nonsurvivors. CONCLUSION: Patients treated with therapeutic hypothermia mayhave prolonged paralysis with continuous infusion of NBMA.Intermittent bolus dosing with close TOF monitoring could be an

alternative strategy to prevent shivering and avoid prolongedparalysis.

50. Impact of the propofol shortage on patient outcomes in acardiothoracic surgical intensive care unit. Rachelle Whiteside,Pharm.D., Edward Horn, Pharm.D., BCPS, David Pavlik, Pharm.D.,Robert Simpson, Pharm.D., BCPS; Allegheny General Hospital,Pittsburgh, PA PURPOSE: On June 16, 2010 Allegheny General Hospital wasaffected by the national shortage of propofol. The preferredalternatives to propofol included lorazepam or midazolam asintermittent doses on an as needed or scheduled basis; if patients failedto achieve adequate sedation with these agents, then the use of acontinuous infusion of either agent could be considered. This studyattempted to determine whether the recent shortage of propofolsignificantly impacted outcomes in cardiothoracic surgical patients METHODS: Medical records of 353 patients in the surgical intensivecare unit (ICU) on a continuous infusion of sedation following cardiacsurgery were retrospectively reviewed four months before and afterthe propofol shortage. Patients’ sedative agent(s) and dose, indicationfor cardiothoracic surgery, duration of mechanical ventilation, ICUlength of stay (LOS), post-procedure LOS, Richmond Agitation-Sedation Scale (RASS) scores, and duration of sedation weredocumented. RESULTS: In both the pre and post-shortage groups a large numberof patients were excluded because they were not on a scheduledsedation regimen, resulting in 31 patients in the pre-shortage groupand 19 patients in the post-shortage group. The shortage did not resultin any differences with respect to duration of mechanical ventilation(p=0.861), ICU LOS (p=0.873), post-procedure LOS (p=0.954), andtime from termination of scheduled sedation to extubation (p=0.860).The percentage of time spent at goal RASS score for patients in thepre-shortage group was 70.1% and 67.2% in the post-shortage group(p=0.741). CONCLUSION: The propofol shortage did not have a negativeimpact on patient outcomes in cardiothoracic ICU patients with use ofa continuous infusion of midazolam or lorazepam. Approximately60% of patients were excluded because they were not on a scheduledsedation regimen, demonstrating that the majority of cardiothoracicsurgical patients can be managed adequately with intermittentinjections of sedation.

51. Evaluating dosing of erythropoiesis-stimulating agents onhemoglobin levels in bloodless medicine patients. Louise-MarieGillis, Pharm.D., Edward T. Horn, Pharm.D., Robert W. Simpson,Pharm.D.; Allegheny General Hospital, Pittsburgh, PA PURPOSE: There is currently limited data regarding the use oferythropoiesis-stimulating agents (ESAs) as an alternative to bloodtransfusions in bloodless medicine patients. The purpose of this studywas to determine if high-dose ESAs are associated with a greaterincrease in hemoglobin levels than low-dose ESAs, and to evaluate theeffect of intravenous iron supplementation on hemoglobin levels inbloodless medicine patients with anemia. METHODS: This was a retrospective, observational study, betweenJuly 2007 and July 2010. Data for 200 patients was collected usingmedical records. Patients were categorized as having received either ahigh-dose (> 900 units/kg/week) or a low-dose (< 900 units/kg/week)of epoetin equivalent. RESULTS: A total of fifty-eight patients were included in the study.For patients with a baseline hemoglobin of less than 7g/dL, the changein hemoglobin per day was not significantly different between patientswho received high-dose (mean 0.153 g/dL, SD 0.209) and low-dose(mean 0.108 g/dL, SD 0.097) ESAs (p=0.279). For all patientsincluded in the study, neither the baseline hemoglobin (<7 g/dL or7–10 g/dL) nor the ESA dosing group had a significant effect on thechange in hemoglobin per day (p=0.772 and p=0.142 respectively).However, the use of intravenous iron supplementation was asignificant predictor for the change in hemoglobin per day (p=0.009). CONCLUSION: Results of this study suggest that when using ESAsas an alternative to blood transfusion in bloodless medicine patients,using higher ESA doses may not provide an additional benefit. Giventhe small sample size of this study, further investigation is warranted.In the absence of more data, doses beyond those listed in the product

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labeling should be used cautiously and with an evaluation of the risksversus benefits. When using ESAs for this indication, the concomitantuse of intravenous iron supplementation is recommended.

52. Effect of home b-blocker use in patients presenting withsubarachnoid hemorrhage. Kevin W. McConeghy, Pharm.D.1, EljimP. Tesoro, Pharm.D.2, Jeffrey J. Mucksavage, Pharm.D.2, Keri S. Kim,Pharm.D.3; (1)University of Illinois at Chicago Medical Center,Chicago, IL; (2)University of Illinois at Chicago, Chicago, IL;(3)University of Illinois Medical Center at Chicago, Chicago, IL PURPOSE: Cardiac dysfunction is a significant complication ofsubarachnoid hemorrhage (SAH) defined as: EKG abnormalities,elevated troponin or LVEF <45%. Propranolol has been associatedreducing mortality and improved neurologic outcomes in patients withSAH. However, incidence of neurocardiogenic injury was notinvestigated in these trials. We conducted a retrospective studyinvestigating whether b-blocker use versus no b-blocker use at time ofictus reduces incidence of cardiac dysfunction. METHODS: Patients admitted for SAH were included if they were:18 years or older, positive diagnosis of SAH, and had aneurysmidentified by cerebral angiography. Patients were excluded if they hadevidence of: non-aneursymal bleed, non-adherence to beta-blockertherapy or spent >24 hours at an outside hospital. The primaryoutcome was neurocardiogenic injury. Univariate and multivariateanalysis was conducted using SPSS version 19.0 (Chicago, Ill). RESULTS: 200 patients were included. The mean age was 54±13.8years, 69% of patients were female, 55% of patients had hypertensionand 45% were smokers. Overall, 42% of patients demonstratedneurocardiogenic injury, 28 (14%) of patients had documented historyof b-blocker use on admission. In the b-blocker and control groupsrespectively, 46.4% versus 41.8% of patients demonstratedneurocardiogenic injury. An LVEF <45% was demonstrated in 7.1 vs.10.4% of patients respectively in b-blocker and control groups. Anelevated troponin was demonstrated in 28 vs. 19% of patientsrespectively in b-blocker and control groups. Pulmonary edema wasfound in 32.1 versus 25.6% of b-blocker and control patientsrespectively. None of these differences were statistically significant.Coronary artery disease was significantly associated withneurocardiogenic injury in regression analysis (OR 6.57 95% CI:1.1–36). CONCLUSION: We found no association between neurocardiogenicinjury and home beta-blocker use at the time of ictus. Patientsadmitted with a history of coronary artery disease are at high risk ofneurocardiogenic injury.

53. Selective Decontamination in the Cardiovascular IntensiveCare Unit: Analysis of the Consumption of Different Groups ofAntimicrobial Agents. María de la Paz Pacheco, Alejandro Santiago,Miguel Sánchez, Head, M.D., Virginia Puebla, Rocío Manzano, JoséA Peña, Ainhoa Arenaza, Pharm.D.; Hospital Clínico San Carlos,Madrid, Spain PURPOSE: To analyze reductions in the consumption of groups ofantimicrobial agents in a cardiovascular ICU and to analyze the effecton costs of the reduction of antimicrobial agents by group. METHODS: We established an SDD protocol for patients undergoingmechanical ventilation for more than 2 days. Patients were treatedwith a decontamination solution in the form of an oral suspension, anoropharyngeal paste and suppositories (first 3 days). The patients alsoreceived prophylactic treatment with ceftriaxone for 3 days. Werecorded the Defined Daily Dose (DDD) of antibiotics before the SDDprotocol was implemented and during the SDD protocol period. Thephysicians were unaware of data collection to avoid interference withdrug prescription. Data analysis was based on total DDD and DDDper patient day (PPD). RESULTS: DDD (PPD): Control Period (Sept 09-Jan 10) SDD Period(Sept 10- Jan 11) Difference Total antibiotics 5085 (2.42) 3615 (2.04)-1470 (-0.38) Carbapenems 685.17 (1.63) 471 (1.29) -214.17 (-0.34)Anti-MRSA* 869.5 (2.06) 545.36 (1.82) -324.14 (-0.24) 3rd-generation cephalosporins 297.5 (0.71) 255 (0.72) -42.5 (0.01) Totalantifungal agents 440 (0.21) 154 (0.09) -286 (-0.12) Amphotericin107.14 (0.05) 0.00 (0.00) -107.14 (-0.05) Echinocandins 189.4 (0.09)49 (0.03) -140.4 (-0.06) Fluconazole 83 (0.04) 55 (0.03) -28 (-0.01)*Linezolid, daptomycin, vancomycin, teicoplanin. Cost (Cost PPD):

The following list shows the overall difference in cost in Euros ofusing an SDD protocol during the 2 periods. The cost PPD is shown inbrackets. Carbapenems: -10,458.67€ (-17.69) Anti-MRSA*: -19,431.07€ (-34.26) Amphotericin: -8,623.04€ (-4.11)Echinocandins: -34,104.13€ (-29.96) Fluconazole: -119.01€ (-0.05) CONCLUSION: The implementation of an SDD protocol leads toreductions in the use of antimicrobial agents. Similarly, the use ofantifungal agents is reduced. These reductions are affected, inparticular, by the reduced use of the more expensive antibiotic agentssuch as anti-MRSA agents and echinocandins.

54. Impact of a pharmacist sedation program on the medical andsurgical mechanically ventilated patient population in a level IItrauma center. Lisa Lederhouse, Pharm.D., Mary Beth Bobek,Pharm.D.; New Hanover Regional Medical Center, Wilmington, NC PURPOSE: Determine the impact of a pharmacist monitoringsedation program in the mechanically ventilated patient population ina community hospital setting. METHODS: This retrospective/prospective study was approved bythe Institutional Review Board. The included population was anymedical or general surgical mechanically ventilated patient receivingcontinuous sedatives and/or analgesics. Excluded from this study wereneurosurgery patients, patients on neuromuscular blockers, and thosewith active seizures, withdrawal symptoms, evidence of increasedintracranial hemorrhage, or profound neurological deficits. Theprimary outcome was length of mechanical ventilation time.Secondary outcomes included total doses of analgesics/sedatives,documentation of the daily wake up assessment, length of ICU stay,and adverse effects. In the retrospective study, data was collected on50 patients admitted during the months of January and February 2010,which served as the control group. In the prospective study, ICUnurses received an in-service on daily wake up assessments by thepharmacist and also completed an online training module. Thepharmacist then ensured wake up assessments were performed dailyand made recommendations regarding appropriate sedatives andanalgesics. The results of the prospective study were compared withthe retrospective study for the primary outcome. RESULTS: The average length of mechanical ventilation was reducedfrom 138.45 hours to 113.0 hours (P=0.6675). Improvements insecondary outcomes were seen, including amount of wake upassessments performed correctly increased from 12.5% to 67.8%(P<0.001) and death rate (14% vs. 36%, P=0.0111). CONCLUSION: While the decrease in mechanical ventilation timewas not statistically significant, there was an improvement insecondary outcomes, including the amount of wake up assessmentsperformed correctly and death rate. As a result of the study, thenursing documentation system was updated to provide furtherguidance on the wake up assessment.

55. Cytochrome P450 eicosanoid levels in cerebrospinal fluid anddelayed cerebral ischemia in subarachnoid hemorrhage patients.Mark K. Donnelly, B.S., Elizabeth Crago, M.S.N., R.N., PaulaSherwood, Ph.D., R.N., CNRN, Michael Horowitz, M.D., SamuelPoloyac, Pharm.D., Ph.D.; University of Pittsburgh, Pittsburgh, PA PURPOSE: Delayed cerebral ischemia (DCI) is a major complicationin subarachnoid hemorrhage (SAH) patients. Eicosanoids formed bycytochrome P450 (CYP) enzymes have been shown to regulatecerebral blood flow (CBF) and contribute to DCI in animal models ofSAH. However, there are few clinical studies investigating the role ofCYP-eicosanoids in DCI due to the difficulty to measure thesecompounds in human CSF. The purpose of this study was to improvethe ability to measure CYP-eicosanoids in CSF from SAH patients,develop temporal concentration profiles, and determine theirrelationship with DCI. METHODS: CSF was collected from ventricular drains on 61 SAHpatients every 12hrs over 14 days. CYP-eicosanoid CSFconcentrations were measured using a published method withmodifications to the collection and processing of the samples. DCIwas determined by the simultaneous presence of neurologicaldeterioration and either angiographic vasospasm or reduced CBFmeasured by transcranial Doppler ultrasound. The mean CYP-eicosanoid concentrations for each patient were dichotomized into lowand high groups and their relationship with DCI was determined using


chi-square analysis. RESULTS: The quantitation limit was lowered from 0.10 to0.01ng/ml when compared to published methods. 20-hydroxyeicosatetraenoic acid (20-HETE) and 14,15- ,11,12- , and 8,9-dihydroxyeicosatrienoic acid (DHET) concentrations were detectablein the majority of samples. The maximum 20-HETE concentration(2.50ng/ml) observed was higher than levels reported to constrictisolated cat cerebral arteries. Also, SAH patients with high 20-HETEconcentrations (>0.05ng/ml) were at higher risk to develop DCI(p=0.048). CONCLUSION: 20-HETE and DHETs were quantitatively assessedin bag CSF from SAH patients. 20-HETE was present atphysiologically relevant concentrations in CSF and may play a role inthe development of DCI after SAH. Future studies can use CYP-eicosanoid temporal concentration profiles to investigate the ability oftheir trajectory patterns to predict SAH patients at high risk for DCI.

56. Improving adherence to an intensive care unit sedationprotocol and effects on patient outcomes. Edward D. Leaders,Pharm.D.1, Phil E. Grgurich, Pharm.D.1, Garret L. Newkirk,Pharm.D.1, William J. Peppard, Pharm.D.1, Karen Brasel, M.D.2;(1)Froedtert Hospital, Milwaukee, WI; (2)Medical College ofWisconsin, Milwaukee, WI PURPOSE: This study was designed to evaluate and implement newstrategies to improve compliance with and optimize the use of arecently implemented intensive care unit (ICU) sedation protocol formechanically ventilated (MV) patients at an academic medical centerin an effort to improve patient outcomes. METHODS: An interdisciplinary group was formed to identifyopportunities to improve the current sedation protocol. Interventionswere immediately implemented in the surgical ICU (SICU),accompanied by staff education, as a pilot prior to hospital-widerollout. Retrospective data was gathered from the electronic medicalrecords of SICU patients who had been on MV for at least 48 hoursand met inclusion criteria for sedation protocol use at time ofintubation. The patients were divided into two cohorts: pre-intervention (n=28) and post-intervention (n=29) to evaluateimprovement to adherence and the effect on patient outcomes. RESULTS: Baseline demographics were similar between groups.Patients were found to receive assessment and documentation of dailysedation vacation (0 vs 18; p=<0.001) and weaning trials (7 vs 24;p≤0.001) in the pre- and post-intervention, respectively. Medicationuse was not found to be statistically significantly different for totallorazepam (mg/kg) equivalents (1.46 vs 1.01; p=0.429), total propofol(mg/kg) (63 vs 32.8; p=0.232), or total fentanyl (mcg/kg) equivalents(72.4 vs 49.8; p=0.212), respectively between the two cohorts.Duration of MV (125.5 hours vs 172.5 hours; p=0.027), length of ICUstay (11.27 days vs 18.5 days; p=0.018), and duration of hospital stay(19.3 days vs 33.5 days; p=0.037) was found to be less in the post-intervention cohort. CONCLUSIONS: Changes to the protocol improved compliancewith sedation vacations, standardized the care of MV patient, andcontributed to reductions in duration of MV and ICU length of stay inthe SICU.

57E. Impact of quetiapine on the resolution of individual deliriumsymptoms: An a priori-designed analysis of a randomized, double-blind, placebo-controlled study. John W. Devlin, Pharm.D., FCCP1,Yoanna Skrobik, M.D.2, Richard Riker, M.D.3, Eric Hinderleider,B.S.4, Russel J. Roberts, Pharm.D.5, Jeffrey J. Fong, Pharm.D.,BCPS6; (1)Northeastern University, Boston, MA; (2)Maisoneuve-Rosemont Hospital, Montreal, QC, Canada; (3)Maine Medical Center,Portland, ME; (4)Northeastern University School of Pharmacy,Boston, MA; (5)Tufts Medical Center, Boston, MA; (6)MassachusettsCollege of Pharmacy and Health Sciences, Worcester, MA PURPOSE: Resolution of individual delirium symptoms in ICUpatients with delirium administered antipsychotic therapy is unclear.We calculated resolution over time and time spent with each of the 10delirium symptoms measured by the Intensive Care DeliriumScreening Checklist (ICDSC) for patients enrolled in a double-blind,randomized, placebo (P)-controlled study evaluating quetiapine (Q)for ICU delirium (Crit Care Med 2010;38;419–27). METHODS: ICDSC symptom data was available for 29/36 patients

randomized [Q (n=15);P (n=14)]. Time to resolution of each ICDSCsymptom (from randomization to study drug discontinuation) wascompared between the Q and P groups using a Kaplan-Meier analysis.For this post-hoc analysis, p<0.10 was considered significant and datawas presented as a median (interquartile range). RESULTS: At baseline, neither the ICDSC score [5(4–6) (Q) vs5(4–6)] nor % with each ICDSC symptom: inattention [93(Q) vs 100],disorientation (93 vs 85), symptom fluctuation (92 vs 87),inappropriate mood (77 vs 43), sleep-wake disturbance (68 vs 71),hypoactivity (64 vs 60), altered level of consciousness (43 vs 40),agitation (36 vs 40) or hallucinations (25 vs 25) differed (all p>0.10).Use of Q led to a shorter time (hrs) to resolution of symptomfluctuation [4(Q) vs 14, p=0.004], inattention (3 vs 8, p=0.10) anddisorientation (2 vs 10, p=0.10) and a longer time to resolution ofagitation (5 vs 1, p=0.04). Q-treated patients spent less % time instudy with inattention [47(0-67) vs 78(43-100), p=0.025],hallucinations [0(0-17) vs 28(0-43), p=0.10) and symptom fluctuation[47(19-67) vs 89 (33-100), p=0.04]. CONCLUSIONS: Q resolves many ICU delirium symptoms fasterthan placebo and results in less time spent with hallucinations,inattention and symptom fluctuation. However, psychomotor agitation,which may be a marker for lower mortality among delirious patientsbut is predictive of worse outcome among patients not delirious, doesnot resolve more quickly with Q. Presented at Presented at the International Congress of the Society ofCritical Care Medicine, San Diego, CA, January 15–19, 2011

58. Comparison of sodium acetate and sodium chloride on clinicaloutcomes in patients with intracranial injury. Ifeoma Asoh,Pharm.D.1, Brian S. Smith, Pharm.D., BCPS1, Raphael Carandang,M.D.1, Jeffrey J. Fong, Pharm.D., BCPS2; (1)UMass MemorialMedical Center, Worcester, MA; (2)Massachusetts College ofPharmacy and Health Sciences, Worcester, MA PURPOSE: Hyperchloremic metabolic acidosis (HMA) is a commoncomplication associated with large volume use of normal saline (NS).Limited evidence supports the use of sodium acetate (NaAcet) incorrecting HMA. We seek to investigate the effect of NaAcet oncorrection of acid-base derangements, ventilation status, andintracranial pressure (ICP) in an adult neurotrauma population. METHODS: This is retrospective database review of patients withintracranial injury admitted between January 2008 and August 2010.Patients were included if they were adults, received NS or NaAcet andhad hyperchloremia (HYPERCL) (chloride >115 mEq/L) or HMA (pH< 7.35, bicarbonate < 15mEq/L). They were excluded if the metabolicacidosis was attributable to other causes. Changes in pH, serumbicarbonate and chloride, minute ventilation and peak ICP wereevaluated. RESULTS: We included a total of 69 patients with 36 assigned to theacetate arm and 33 to the saline arm. Baseline demographics weresimilar with a mean age of 50 years, 84% requiring mechanicalventilation, and a median admission GCS score of 8. At baseline,HMA occurred in 7(19%) of the acetate and 4(12%) of saline arm. Allpatients had HYPERCL. At 48 hours, acidosis corrected in all patientswith HMA with changes of pH > 0.1 unit occurring more often withNaAcet 47.8% vs. 18.1% (p=0.155). By 96 hours, chloride levels hadnormalized in more patients in NS 56.3% vs. 36.1% (p=0.096). Therewere no observed differences in minute ventilation (8534± 3828 vs.9267±2654, p=0.557) or peak ICP readings (30.4±14 mmHg vs.53±49.4 mmHg, p=0.19). NaAcet was associated with more metabolicalkalosis (75% vs. 21.2%, p=0.00000804). CONCLUSION: NaAcet does not appear to correct HMA faster,negatively impact ventilation status or peak ICP, however, manypatients developed metabolic alkalosis. Larger studies are needed tobetter describe the role of sodium acetate in critically ill patients.

Dermatology

59. Safety of biologic treatments for moderate to severe plaquepsoriasis: a systematic review, basic meta-analysis, and Bayesianmixed treatment comparison. Erica L. Baker, Pharm.D.1, Craig I.Coleman, Pharm.D.2, Kurt M. Reinhart, Pharm.D.1, Olivia J. Phung,Pharm.D.3, Ajibade Ashaye, MBBS, M.P.H.1, Lisa Kugelman, M.D.1,Wendy T. Chen, Pharm.D.4, C. Michael White, Pharm.D., FCCP,

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FCP2, Jeff Mather, M.S.1, Carla M. Mamolo, Ph.D.5, Joseph C.Cappelleri, Ph.D.6, William L. Baker Jr., Pharm.D.7; (1)HealthOutcomes, Policy and Economics (HOPE) Collaborative Group,Hartford, CT; (2)University of Connecticut, Hartford, CT; (3)WesternUniversity of Health Sciences, Pomona, CA; (4)Beth Israel DeaconessMedical Center, Boston, MA; (5)Pfizer Inc., Groton, CT; (6)Pfizer,Inc., Groton, CT; (7)University of Connecticut School of Pharmacy,Farmington, CT PURPOSE: To conduct a systematic review and meta-analysis inorder to evaluate the impact of biologics on various safety endpointsin adults with moderate-to-severe plaque psoriasis. METHODS: A systematic literature search of MEDLINE and theCochrane Database was performed through May 2009 to identifyEnglish-language trials of biologic agents versus either placebo oreach other in adults with moderate-to-severe plaque psoriasis and thatreported the desired outcomes. Basic [odds ratio (OR), 95%confidence interval] and Bayesian mixed treatment comparisons(MTC) [OR, 95% credible interval] meta-analyses were conducted foreach end point. Biologics were evaluated both individually and bypharmacologic class. Safety endpoints included total withdrawals,withdrawals due to adverse events, total infections, upper respiratoryinfections, cancer, and various laboratory abnormalities. RESULTS: Thirty-eight studies met eligibility criteria. Biologicsincluded the anti-T cells agents (alefacept, efalizumab), anti-tumornecrosis factor alpha (TNF) agents (adalimumab, etanercept,infliximab), and anti-interleukin 12/23 agents (ustekinumab,briakinumab). Reductions in total withdrawals were seen with both theanti-TNFs (0.36, 0.22–0.60) and anti-interleukins (0.362; 0.23–0.57)versus placebo. The MTC model suggested that the anti-interleukinshad lower odds of total withdrawals versus the anti-T cells (0.31,0.10–0.92). Only the anti-interleukin agents significantly reduced theodds for withdrawing due to adverse events versus placebo (0.43,0.20–0.90). The anti-T cells (1.29, 1.07–1.56) and anti-TNFs (1.30,1.04–1.64) significantly increased the odds of infections versusplacebo. No effects on cancer or upper respiratory infections wereseen in any analysis. Data on laboratory abnormalities, including liverfunction and serum creatinine, was inconsistent and did not lendthemselves to statistical pooling. CONCLUSIONS: The anti-interleukins were amongst the besttolerated agents while anti-T cells increased events such aswithdrawals and infections. Many endpoints were limited by poor datareporting, so no firm conclusions could be made about them.

Drug Information

60. The prevalence and quality of noninferiority studies in majormedical journals. McKenzie C. Ferguson, Pharm.D., BCPS, Erin M.Timpe, Pharm.D., BCPS, Jeff Harp, Pharm.D.; Southern IllinoisUniversity Edwardsville, Edwardsville, IL PURPOSE: This study evaluated the number and methods ofnoninferiority studies in 3 major medical journals over time. The aimwas to determine if the number of noninferiority studies has increasedand if so, to raise awareness and stress the importance of properdesign and evaluation of these types of trials. METHODS: Original research articles of three well-known medicaljournals, The New England Journal of Medicine (NEJM), The Journalof the American Medical Association (JAMA), and The Lancet wereassessed for the number of noninferiority studies present during theyears 2000 and 2010. Appropriateness of design was assessed bydetermining if the following were included: a defined margin of effect,sample size calculation, and confidence intervals. The type of analysis(per-protocol or intention-to-treat) was also evaluated. Per-protocol isthe preferred method of analysis for noninferiority studies. RESULTS: Of 1,238 studies assessed, 3.4% (n=42) were determined tobe noninferiority studies. There was a statistically significant increase inthe total number of noninferiority studies between 2000 and 2010. As apercentage of total studies assessed in 2000 and 2010, noninferioritystudies represented 0.9% of total studies in 2000 and 6.5% in 2010. Of48 equivalence and noninferiority studies, more than 95% had a definedmargin of effect, sample size calculation and confidence intervalreported. Six studies (12.5%) utilized only per-protocol analyses vs. 30(62.5%) that utilized intention-to-treat and 12 (25%) which utilizedboth. In total, only 10 (20.8%) met all criteria for appropriateness.

CONCLUSION: In the past decade, the number of noninferioritystudies published in major medical journals has increased. Healthcareprofessionals should understand how to properly evaluatenoninferiority study methods.

Education/Training

61. Ready AND Willing: A Self-Assessment Tool to DetermineStudent Pharmacists’ Confidence to Optimize Drug Therapy.Stuart T. Haines, Pharm.D., BCPS, Lisa Lebovitz, J.D., Deborah A.Sturpe, Pharm.D., BCPS, David Roffman, Pharm.D., BCPS;University of Maryland School of Pharmacy, Baltimore, MD PURPOSE: Managing patient care and leading practice changerequires self-confidence. We developed a tool to assess student self-confidence to perform the professional competencies needed tooptimize drug therapy. METHODS: The University of Maryland School of Pharmacyestablished sixteen terminal performance outcome (TPO) statementsthat describe specific abilities all graduates should possess. ThreeTPOs focus on the ability to optimize drug therapy outcomes inindividual patients: (1) Participate in the development of patient-specific therapeutic plans; (2) Maximize appropriate drug usebehaviors; and (3) Participate in the process of monitoring patientoutcomes. Each TPO has a list of associated tasks. A survey tool wasdeveloped that describes three case scenarios: one communitypharmacy, one hospital pharmacy, and one health maintenanceorganization. Each scenario includes a list of the key tasks that mustbe performed to address the problems faced in the case. Each task isanchored in the school’s TPOs. Students are asked to envisionthemselves in each case scenario and rate their currentability/confidence to perform the tasks in the context of the scenario.Students are given the survey shortly after admission to the school andperiodically thereafter as they progress through the professionalcurriculum. RESULTS: At baseline, most students indicated they could notperform the key tasks in the given scenario “without substantialsupervision” (ranging from 54 to 98% depending on task andscenario). As students progressed through the curriculum, thepercentage of students who indicated they could not perform the taskwithout substantial assistance declined significantly (ranging from 27to 78% Spring P1 year and 1 to 5% Spring P2 year) (p<0.001). CONCLUSIONS: This unique self-assessment tool may providepharmacy educators valuable insights regarding student progressiontoward curricular outcomes and may be a useful adjunct to otherinstitutional assessment methods to meet accreditation requirements.

62E. Assessment of Students’ Readiness for Self-directedLearning. Therese Poirier, Pharm.D., M.P.H.1, Radhika Devraj,Ph.D.2; (1)Southern Illinois University Edwardsville, Edwardsville,IL; (2)Southern Illinois University Edwardsville School of Pharmacy,Edwardsville, IL PURPOSE: : To assess students’ readiness for self-directed learningduring the P1 year prior to beginning coursework; to determine therelationship of various students characteristics to students’ self-directed learning readiness (SDLR) and its subscales; and to compareP1 students’ SDLR and its subscales to pre-APPE and post-APPE datafrom another pharmacy school. METHODS: Eighty-three P1 students completed the Fisher’s SDLRelectronic survey. Independent t- test, one way ANOVA, reliabilityanalysis and Z-test analysis were completed. RESULTS: Cronbach’s alpha revealed high reliability (0.920) for theSDLR and its subscales. The mean SDLR score was 166.42 (Range:131.53 to 197). 84% scored a high readiness (SDLR > 150). Nosignificant differences in SDLR and subscales scores weredocumented based on gender, age, pre-pharmacy coursework andPCAT scores. Statistically significant differences (p<0.05) were notedin self control scores depending on leadership experiences. Similarlysignificant differences in self management scores based on pre-pharmacy GPA were noted. Z-test analysis revealed that P1 studentshad significant differences in SDLR, self control and desire forlearning scores compared to pre-APPE students and significantdifferences in self management and desire for learning compared topost-APPE students from another pharmacy school.


CONCLUSION: Baseline analysis revealed high level of readinessfor self-directed learning among P1 students and few differencesassociated with demographic variables. However, P1 studentsappeared to have higher readiness for self directed learning comparedto more advanced students at another pharmacy school. This mayimply that these students should be well prepared to navigate thepharmacy curriculum. Presented at American Association of Colleges of Pharmacy AnnualMeeting, July 2011

63. Improving student desires to advocate for the pharmacyprofession after attendance to a state board of pharmacy meeting.Kristine C. Willett, Pharm.D., Cheryl R. Durand, Pharm.D., Alicia R.Desilets, Pharm.D.; Massachusetts College of Pharmacy and HealthSciences, Manchester, NH PURPOSE: Colleges and Schools of Pharmacy continue toemphasize the importance of professionalism in their curricula. Thepursuit of professionalism requires students to understand the value ofadvocacy upon entrance into the profession. The purpose of this studyis to determine change in student attitude toward pharmacy advocacyfollowing attendance to a state board of pharmacy meeting. METHODS: The methods of this study have been approved by theInstitutional Review Board. Doctor of Pharmacy students enrolled inan accelerated pharmacy program were asked to attend a state board ofpharmacy meeting. Students were asked to complete a shortquestionnaire to reflect on their experience. Analysis of data was doneusing frequencies and percentages. Student responses will provideinformation on the impact of attendance to a state board of pharmacymeeting on their desire to become actively involved in the advocacy oftheir profession. RESULTS: Twenty-eight students completed the questionnairefollowing attendance to a state Board of Pharmacy meeting. Of thestudents that attended, 15 (53.5%) reported an increase in desired tobecome more involved in the advocacy for the profession ofpharmacy. Seven (25%) students reported that attendance enhancedtheir existing desire to become involved. Additionally, students offeredcomments expressing the value of the Board of Pharmacy and howtheir experience altered their perception of the need to becomeactively involved to enhance the practice of pharmacy both locally andnationally. CONCLUSION: There is value in exposing students to professionalgroups and organizations. Attendance at a state Board of Pharmacymeeting provided students with exposure the importance of becomingactive in their profession as students and upon graduation.

64. Perception of Advanced Pharmacy Practice Experiencestudents on inpatient internal medicine rotations: a healthcareprovider perspective. Jason W. Lancaster, Pharm.D., BCPS,Margarita V. DiVall, Pharm.D., BCPS, Mark A. Douglass, Pharm.D.,Michael J. Gonyeau, BSPharm, Pharm.D., BCPS, Adam B. Woolley,Pharm.D., Adrian Wong, B.S.; Northeastern University School ofPharmacy, Boston, MA PURPOSE: Currently there are no known published reports ofhealthcare provider perception of Advanced Pharmacy PracticeExperience (APPE) students within the inpatient internal medicinesetting. We therefore seek to assess APPE students’ perceived value byproviders in this setting. METHODS: A brief, anonymous online survey was distributedbeginning in March 2011 via secure e-mail to inpatient internalmedicine providers at medical centers where Northeastern Universitystudent pharmacists completed an internal medicine rotation. Dataincluded extent of student pharmacists’ involvement in patient care,appropriateness of therapeutic recommendations, participation ineducation of medical teams and overall benefit. RESULTS: Of those surveyed, 32 responded (56.1%) and a majorityhad worked with ≥3 student pharmacists. A vast majority believedstudent pharmacists were 1) prepared for daily rounds (90.6%), 2)active participants in patient care (84.4%), 3) in possession of thenecessary patient-specific information to be beneficial (93.8%), and 4)able to respond to drug information questions appropriately (87.5%)and accurately (96.9%). Additionally, half of those respondingindicated student recommendations led to changes in medicalmanagement of patients. Furthermore, for those students providing

topic discussions, providers reported that they were of great benefit(90%), as well as potentially leading to changes in their personalpractice (90%). Overall, 96% of the providers reported that studentpharmacist involvement within medical teams provided some level ofbenefit; with 47% stating they were ‘very beneficial’. CONCLUSION: Provider’s perception of the value of pharmacystudents was generally positive regardless of medical center. Findingsindicate student pharmacists are beneficial to the responding providersin a variety of patient-care areas. Additional efforts to educate medicalteams of potential roles of student pharmacists in the team are criticalto further establish provider and medical team acceptance.

65. Qatar University pharmacy students interest and concernsrelated to international professional experience rotations. Sara Al-Dahir, Pharm.D., BCPS, Sarah Amering, Pharm.D.; Xavier Universityof Louisiana, New Orleans, LA PURPOSE: This survey for Qatar University pharmacy students wasconducted to determine 1) knowledge of global health; 2) interest inexchanges and 3) personal and logistic barriers to internationalprofessional experience rotation exchanges. METHODS: In this on-line survey, conducted between January andJune 2011, participants were recruited from all students enrolled inQatar University Pharmacy professional degree program. The surveydomains addressed 1) demographic characteristics of the respondents;2) knowledge of global health trends; 3) knowledge of the regulatorystatus of select medications in different countries; 4) interest in aninternational exchange and 5) areas of concern related to participationin an international pharmacy student exchange program. Descriptivestatistical analyses and group comparisons were carried out usingcorrelation statistics and linear regression analysis. RESULTS: A total of 60 surveys were collected from students intheir first through fourth professional year (77% response rate, N=77).Eighty-eight percent of the students were interested or very interestedin an international pharmacy exchange program, with Canada (87%)and the United States (88%) identified as preferred countries to engagein medication management (77%), pharmacy dispensing (72%) andresearch (60%). The Qatari students identified issues related tohousing (67%), overall cost (57%), cultural differences (55%) andpersonal safety (52%) as areas of concerns regarding an exchange. Inthe domains of general global health trends related to infectiousdisease and medication regulation, the students performed at 32% and18% correct responses respectively. CONCLUSION: Students from the College of Pharmacy in Qatar,though interested in international exchange programs, have significantconcern regarding safety and cultural barriers to such a program.Qatari students interested in an international exchange will requireadditional education on global health trends and medication regulationin North America. Host institutions should pursue opportunities toaddress these concerns as efforts are established toward reciprocalexchanges.

66E. BA4LL: Bounce around 4 larger learning. Utilization ofexercise balls for chairs on an internal medicine APPE. Tracey L.Mersfelder, Pharm.D.; Ferris State University, Big Rapids, MI PURPOSE: Exercise balls are becoming popular in the classroom.Little has been published on their incorporation and acceptance into anadult learner environment. The main objective of this study was todetermine the feasibility and acceptability of using exercise balls inplace of chairs in a small group environment. METHODS: Feasibility was evaluated by purchasing exercise ballsfor the clinical site and price, size, and limitations were recorded. Toaddress acceptability, pre- and post-surveys were administered to theAPPE internal medicine students at one site. This project was IRBapproved. RESULTS: A total of seven balls are available for the students. Thecost of the balls ranged from $14–$23. The best universal size is the75 cm ball. The biggest limitation was finding the correct ball size foreach student with the fixed table height. To date, 16 students havecompleted the pre-survey, and fifteen students have completed the postsurvey. All students used the exercise balls at least once. One-half feltthe balls would be a distraction at first but this decreased to 1/3. At theend of the rotation, 93% students stated that the exercise balls shouldbe an option in other classroom settings.

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CONCLUSION: Providing exercise balls for students on theirinternal medicine APPE is feasible and was accepted by the students.Consideration should be made to provide exercise balls for otherclassroom settings. Presented at Lilly Conference on College and University Teaching inSeptember 2011. (website:http://lillyconferences.com/tc/default.shtml).

67. Impact of a web-based learning module and faculty preceptoron experiential pharmacy students’ pain management confidenceand competence. Mark A. Douglass, Pharm.D.1, Jason Lancaster,Pharm.D., BCPS1, Margarita V. DiVall, Pharm.D., BCPS2, Michael J.Gonyeau, BSPharm, Pharm.D., BCPS2, Adam Woolley, Pharm.D.,BCPS1; (1)Northeastern University Department of PharmacyPractice/Boston Medical Center, Boston, MA; (2)NortheasternUniversity School of Pharmacy, Boston, MA PURPOSE: To evaluate the impact of a web-based learning module(WBLM) and faculty preceptor on experiential pharmacy students’pain management confidence and competence. METHODS: Ninety nine pharmacy students completing their fourthprofessional year were invited to participate in a supplemental web-based learning module (WBLM), designed to improve the followingpain management skills: managing chronic-continuous pain (CCP),equianalgesic dose conversion (EDC), breakthrough pain (BP), andopioid side effects (OSE). A questionnaire was then distributed whichassessed students’ self-reported comfort level (confidence) and theirknowledge (competence) of these skills using standardized casevignettes. Students’ were asked if they completed their internalmedicine rotation with a university-based faculty preceptor. A Fisher’sexact test was used to compare each outcome. RESULTS: The questionnaire response rate was 76% and 24%completed the WBLM. WBLM participants were as or more confidentthan non-participants with three pain skills (CCP, 71% vs 67%, p=0.8;EDC, 79% vs 67%, p=0.4; BP, 75% vs 75%, p=1.0) and as or morecompetent with all skills (CCP, 38% vs 29%, p=0.6, EDC, 67% vs65%, p=1.0, BP, 25% vs 16%, p=0.3, and OSE, 80% vs 61%, p=0.2).Faculty precepted students’ reported more confidence with all skills:CCP, 73% vs 58%, p=0.2; EDC, 76% vs 62%, p=0.3; BP, 76% vs70%, p=0.6, and OSE, 76% vs 73%, p=0.8, and were more competentwith EDC (70% vs 58%, p=0.3), BP (20% vs 15%, p=0.7, and OSE(69% vs 65%, p=0.8). CONCLUSION: Students who utilized the WBLM reported moreconfidence with CCP, EDC, and BP and were as or more competentwith all pain skills. Faculty precepted students’ reported moreconfidence with all skills and were more competent with EDC, BP,and OSE. A lower than expected number of students completed theWBLM, which may have accounted for the non-significant studyfindings.

68. Prospective evaluation of student-led presentations as asuccessful teaching method for achieving critical care competency.Daniel R. Malcom, Pharm.D., Jennifer L. Hibbs, Pharm.D., BCPS;Sullivan University College of Pharmacy, Louisville, KY PURPOSE: Guidance for critical care pharmacy didactic education islimited, both for instructional techniques and evaluation of outcomes.The study purpose was to assess the efficacy of student-ledpresentations and class discussions as a teaching method in a criticalcare elective course. METHODS: In a critical care elective of a 3 year acceleratedprogram, P2 students were asked to prepare and deliver 50-minutepresentations on critical care topics generated using the ACCPPharmacotherapy Toolkit. Designed to complement thepharmacotherapeutic curriculum, topics included: hypertensive crisis,COPD exacerbation, antifungal therapy, intensive care associateddelirium, nutrition support, liver transplantation. A faculty generatedcritical care competency test of 20 multiple choice questions wasadministered before the start of the course and upon completion. Pre-and post-test scores were compared using student t- tests. Total meanscores and mean scores for questions related to material taught in thecourse were evaluated with significance set at 5%. Informed consentwas received as part of institutional review board approval. RESULTS: Of 24 students enrolled, all students completed the study.By the elective’s conclusion, discussion related to 9 of 20 questions on

the competency were conducted by student presentations. The totalmean score significantly improved 11.5% on the post test compared tothe pre-test score (pre-test 56% vs post-test 67.5%, p<0.05). 16.2%improvement was shown on the 9 questions which pertained directlyto subject matter taught during the course (pre-test 59.2% vs post-test75.2%, p<0.05). CONCLUSION: Students displayed statistically greater mean scoreson the post test for all 20 questions, and acheived 75.2% on questionsrelated to material covered in class. Statistically significantimprovement on questions specific to critical care material reviewedduring the course indicate the use of student-led presentations issuccessful in improving student competency and may be a beneficialteaching method for critical care pharmacotherapeutics in anaccelerated program.

69. Dietary supplement education in a senior population. KimberlyG. Elder, Pharm.D.1, Sarah A. Nisly, Pharm.D., BCPS2; (1)IndianaUniversity Health Methodist Hospital, Indianapolis, IN; (2)ButlerUniversity College of Pharmacy and Health Sciences, Indianapolis, IN PURPOSE: Potential dangers with dietary supplements include thelack of regulation by the Food and Drug Administration and thepossibility of drug-supplement interactions. The primary objective ofthis study was to determine the effectiveness of a pharmacist driveneducational seminar in a local senior population. METHODS: Initially, a needs-assessment interview was conducted ata health fair within a local senior organization. Interviews focused ondietary supplement use were delivered to study participants. Interviewresponses were then analyzed to determine the most commonly useddietary supplements. Next, an educational seminar focusing on generaldietary supplement information and the most commonly usedsupplements in the initial population was created and delivered. Pre-and post-surveys were administered to gauge baseline knowledge andimpact of pharmacist education. Additionally, results were analyzedfor change in attitudes about supplements. RESULTS: Forty-nine participants were interviewed about dietarysupplement use at the initial health fair. Participants were primarilyAfrican American females with a mean age of 72.6 ± 7.8 years.Among those, 81.6% were taking at least one supplement. The mostcommonly used supplements were calcium (n=23), multivitamins(n=22), and fish oil (n=13). Approximately 180 seniors attended thesubsequent educational seminar. Participants reported being mainlyHispanic females with a mean age of 72.3 ± 7.9 years. Knowledgestatistically significantly improved from baseline for all six questionsposed to study participants. The program was well received, andattitudes about dietary supplements changed as a result of viewing theseminar. CONCLUSION: Dietary supplements were commonly used by thestudy population for various indications. Education by pharmacists isan effective method to increase knowledge and awareness aboutdietary supplements among this population.

70. Patient-focused pharmacotherapy notes in a cardiovasculartherapeutics course: a standardized approach. Angela O. Shogbon,Pharm.D., BCPS, Lisa M. Lundquist, Pharm.D., BCPS, Kathryn M.Momary, Pharm.D., BCPS; Mercer University College of Pharmacyand Health Sciences, Atlanta, GA PURPOSE: To evaluate the effectiveness of utilizing a standardizedapproach to patient-focused pharmacotherapy notes, specificallySubjective Objective Assessment Plan Education (SOAPE) noteformat, to improve students’ knowledge of patient-focuseddocumentation in a cardiovascular therapeutics course. METHODS: A total of five weekly patient-case discussion sessionswere incorporated into a cardiovascular therapeutics course forsecond-year pharmacy students. Each week, students came preparedfor small-group discussions on a patient case they completed ahead oftime, utilizing the SOAPE note format. Then, students worked-upanother patient case and submitted a SOAPE note for a grade. ASOAPE note approach to patient cases was also incorporated into alllectures throughout the course. A pre-test and post-test assessingstudents level of confidence in preparation of SOAPE notes wereadministered at the beginning and end of the course, respectively.Perception of confidence was ranked on a 4-point Likert scale with4=strongly agree and 1=strongly disagree. Data collection for this


study was approved by the IRB and students voluntarily signedinformed consent prior to participation. Scores on the pre-tests, post-tests, and student performance on SOAPE notes were comparedutilizing descriptive statistics and paired t-tests. RESULTS: A total of 121 (91.7%) students completed both the pre-tests and post-tests. There was significant improvement in student’sconfidence in writing SOAPE notes by the end of the course, with amean(SD) score of 2.89(0.46) on pre-test and 3.53(0.36) on post-test(p<0.001). Students’ mean(SD) performance on the first and finalSOAPE note in the course was 89.6%(8.34) and 93.2%(6.71),respectively (p<0.001). There was no significant difference inconfidence or performance scores between students with priorexperience in writing SOAPE notes, and students without experience. CONCLUSION: A standardized approach to patient-focusedpharmacotherapy notes may enhance students’ understanding andconfidence to perform this vital task on experiential patient carerotations and in clinical practice.

71. Community pharmacists in the State of Qatar: a survey oftheir smoking cessation knowledge and educational interests.Maguy S. El Hajj, Pharm.D., Reem R. Al Nakeeb, B.S.Pharm.Candidate, Rajaa A. Al Qudah, B.S.Pharm. Candidate; QatarUniversity College of Pharmacy, Doha, Qatar PURPOSE: Cigarette smoking is one of the preventable causes of illhealth in Qatar. Qatar community pharmacists are in an ideal positionto play an important role in smoking cessation. This role necessitatesadequate smoking cessation knowledge and education. The studyobjectives were to assess Qatar community pharmacists’ smokingcessation knowledge and to gauge their perceptions of which aspectsof smoking-related education would be most interesting. METHODS: A pretested survey was used to solicit communitypharmacists’ anonymous responses. The survey was designed afterreviewing relevant smoking cessation literature. A phone call wasmade to all community pharmacists in Qatar to request theirparticipation. Interested pharmacists were sent the survey link byemail or by fax. Data was descriptively analyzed using the StatisticalPackage of Social Sciences software version 18. RESULTS: Over 20 weeks, we collected 112 surveys (35% responserate). Smoking cessation knowledge was evaluated using 8 true orfalse questions. Thirty seven percent of respondents scored less than60% and 13% scored more than 80%. The mean score was 61% with astandard deviation of 17%. Eighty-nine percent of respondentsindicated that they have not received before any smoking cessationeducation. Nevertheless, at least 70% indicated that they wereinterested in receiving additional smoking cessation education.Respondents were mostly interested in receiving education onmotivating smokers to quit and on counseling on behavioraltechniques (89% and 86% respectively). Sixty nine percent indicated apreference for mailings of printed materials as method of informationdelivery. CONCLUSION: Despite their low smoking cessation knowledge,Qatar community pharmacists are interested in receiving additionalsmoking cessation education. A smoking cessation education programshould be offered to these pharmacists to give them the knowledgethey need to be competent smoking cessation counselors.

72. Pharmacy students’ attitudes toward pharmaceutical care inQatar. Maguy S. El Hajj, Pharm.D., Ayat S. Hammad, BSPharm,Candidate, Hebataila M. Afifi, BSPharm, Candidate; Qatar UniversityCollege of Pharmacy, Doha, Qatar PURPOSE: Pharmacy practice has recently shifted from medicationsupply to pharmaceutical care (PC). Pharmacy educators must preparestudents to provide PC. Their responsibilities are not only limited togive students knowledge and communication skills but to motivatethem to perform PC. The study objectives were to investigate Qatarpharmacy students’ attitudes toward PC, to identify the factors thatinfluence their attitudes toward PC, and to recognize their perceivedbarriers for PC provision. METHODS: Qatar University college of pharmacy is the onlypharmacy college in Qatar. A cross sectional survey of QatarUniversity pharmacy students was made. The students completed anonline anonymous survey designed based on Standard PharmaceuticalCare Attitudes Survey (PCAS). Data was descriptively analyzed using

Statistical Package for the Social Sciences version 18. Influence ofsociodemographic characteristics on students’ attitudes was assessedusing Kendall’s tau_b test. RESULTS: Over 4 weeks, 46 surveys were submitted (90% responserate). All respondents agreed that PC practice is valuable and that thepharmacist primary responsibility is to prevent and resolve medicationtherapy problems. Most respondents believed that PC provision isprofessionally rewarding (96% of respondents), and that allpharmacists should provide PC (91%). Highly perceived barriers forPC provision included lack of access to patient medical information(76% of respondents), inadequate drug information sources in thepharmacy (55%) and time constrains (53%). Professional year andpractical experience duration were significantly inversely associatedwith students attitudes (correlation coefficients are -0.30 and -0.37respectively p <0.05). No statistically significant correlations existedbetween other characteristics and students attitudes. CONCLUSION: Qatar pharmacy students indicated positive attitudestoward PC. However, they perceived several barriers for PC provision.Efforts should be exerted by Qatar government to help these futurepharmacists in overcoming these barriers.

73. Implementation of and experience with a locally-developedsummative exit exam delivered to Pharm.D. students prior tograduation. Lamis Karaoui, Pharm.D., BCPS, Hani Dimassi, Ph.D.;Lebanese American University, Byblos, Lebanon PURPOSE: To create a valid assessment tool to evaluate studentknowledge and educational outcomes prior to graduation from thedoctor of pharmacy program. METHODS: The Lebanese American University School of Pharmacy– ACPE accredited – administers a summative locally-developedexam to fourth professional year (P4) graduating Pharm.D. studentsannually in June. In 2009, the Exit Exam (EE) was first delivered onBlackBoard®. In 2010, it was redesigned to simulate in content the2010 NAPLEX competency statements. An EE committee of facultymembers was formed to review and update the previously existingquestion pool, standardize exam questions, and supervise the processof implementing and administering the EE. The number of questionscollected from each course is proportional to the number of credithours devoted to that course in the curriculum. EE is an electronicexam consisting of 185 multiple-choice questions, each with a stemand four choices. The estimated time to complete the exam is 4.5hours. RESULTS: EE 2010 focused on the following three areas of the 2010NAPLEX Blueprint: therapeutics (Area 1, 56%), preparation anddispensing (Area 2, 33%) and public health (Area 3, 15%). Overallstudent performance on the EE shows a quasi-consistent trend (overallmean ranged between 52.59 and 56.15 over 100) for the years 2007,2009 and 2010, with mean scored below 50 in 2008. Interestingly,better results were observed on Areas 2 and 3 as opposed to Area 1with means of 58.99, 61.89 and 51.96 over 100 respectively. EE doesnot bear weight on grade point average or graduation and students arenot requested to prepare for it. CONCLUSION: The obtained results measure retention ofinformation of the graduating Pharm.D. student. EE is a promisingtool for programmatic assessment; better yields are expected withgrade allocation and mandatory preparation. EE provides guidance forLebanese graduates sitting for the NAPLEX.

74. Evaluation of student pharmacists’ awareness and perceptionsof board certification. Kristina D. Wood, Pharm.D.1, Bella H. Mehta,Pharm.D.1, Maria Pruchnicki, Pharm.D.1, Jennifer L. Rodis,Pharm.D.1, Kyle Porter, MAS2; (1)The Ohio State University Collegeof Pharmacy, Columbus, OH; (2)Ohio State University Center forBiostatistics, Columbus, OH PURPOSE: The American Pharmacists Association (APhA) and theAmerican College of Clinical Pharmacy (ACCP) have publishedpapers on the importance and value of certification through the Boardof Pharmacy Specialties (BPS) and have identified a role for schoolsof pharmacy to promote the value of certification to students. Theobjectives of this study were to: 1) determine awareness of BPScertification by current student pharmacists at all levels of pharmacyeducation, 2) evaluate student perceptions of effective educationalformats for learning about BPS certification, and 3) assess students’

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interest in obtaining BPS certification in future careers. METHODS: State boards of pharmacy in all 50 states were contactedto request licensed intern contact information; all students with validemail addresses were invited to participate in an online survey.Participants were asked about awareness of BPS, where they learnedabout certification, interest in attaining certification, futureprofessional plans, and demographics. RESULTS: Nine state boards provided 7,251 eligible email addresses,with 1,108 survey responses (15.3% response) included for analysisrepresenting students from schools in 39 states. A majority ofrespondents (73.2%; n=750) were aware of board certification andidentified learning about BPS most from faculty members (n=509) andpreceptors (n=289), primarily in required courses (n=311) andadvanced pharmacy practice experiences (n=238). When asked aboutfuture plans, 43.3% (n=472) stated they were likely to pursue BPScertification, 41.1% (n=449) were undecided, and 15.6% unlikely(n=170). CONCLUSION: Most respondents were aware of certification,learning the most through didactic and experiential activities, andmany indicated they are likely to or undecided about pursuing BPScertification. Respondents unaware of or undecided about BPScertification represent an opportunity for colleges of pharmacy andprofessional organizations to formalize their role in student educationabout BPS and advocacy efforts.

75. Student-created public service announcements: a novelapproach to attaining public health competency in the pharmacycurriculum. Kim Coley, Pharm.D.; University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: We set out to implement a more creative way to engagestudents in their own public health awareness in the pharmacycurriculum through the use of student-created public serviceannouncement (PSA) videos. Students’ perceptions of the process andoutcomes were assessed. METHODS: Students in the Professions of Pharmacy 6 course wereassigned to create a 1–2 minute PSA video from a list of selectedtopics. Topics were important public health issues where pharmacistsplay a vital role as public health providers and educators (e.g.,vaccinations, antibiotic resistance, medication adherence). Studentsposted their videos on YouTube so that their peers could evaluatethem. PSAs were evaluated on creativity, content, message, andoverall impact. Students also evaluated the overall process andoutcomes of the project. RESULTS: Students worked in groups of six to create 18 PSA videos.Sixty percent of the groups had at least one group member that wassomewhat knowledgeable on how to make videos. Eighty-nine percentof students felt the take-home message of the PSAs was achieved and96% rated their peers’ PSAs as good to excellent. On a 5-point Likertscale, 30% strongly agreed that creating a PSA was an effectivemechanism to learn about important pharmacy-related public healthtopics, 48% were neutral, and 22% felt it was ineffective. The abilityto be creative, cited by 55% of students, was the aspect that theyenjoyed most. The main criticism of the assignment was its timing,which was at the end of the semester and conflicted with several othercourse assignments. CONCLUSION: PSA videos are a creative way to engage students inself-directed learning of important public health topics. Providingstudents with additional support on video-editing and improving thetiming of the assignment should increase overall satisfaction with thislearning activity.

76. Impact of Unlimited Access to Asynchronous Online LectureViewing on Student Outcomes in a Therapeutics course. SuzanneG. Bollmeier, Pharm.D., BCPS, AE-C, Amy Drew, Pharm.D., BCPS,Philip J. Wenger, Pharm.D., BCPS, Alicia B. Forinash, Pharm.D.,BCPS; St. Louis College of Pharmacy, Saint Louis, MO PURPOSE: The purpose of this study is to find a correlation betweenonline lecture viewing with Therapeutics II (T2) 2010 course gradesand attendance and also compare between final course grades with theprevious year (2009). METHODS: Lectures were recorded via ® software and availablefor 72 hours in 2009 and for the entire semester in 2010. Attendancewas recorded in aggregate in 2009 and individually in 2010. Pearson’s

correlation was used to analyze lecture viewing with final grade andclass attendance, and final grade and attendance. T-test was used tocompare final course grades in 2009 and 2010, and ANOVA was usedto compare final grades in 2008 (no online access), 2009, and 2010.Students completed a pre- and post-semester survey regarding lectureaccess in 2009 and 2010. RESULTS: No correlation was found between: lecture viewing andoverall grades, lecture viewing and individual attendance, or finalgrade and attendance. Course grades were not affected by amount oflecture access time. Pre survey results showed: 97% of students wouldaccess posted files in addition to previous study habits and theyintended to view the files within one week of lecture (64%). Also 97%postulated it would not influence their class attendance. Post surveydata showed: 85% used files to complete lecture handouts, 87% usedfiles to answer questions instead of contacting the and 93% requestedmore lecture files be posted in future classes. When not in class, 77%reported they watched the posted file, and 94% reported ® did notinfluence their attendance. CONCLUSIONS: Having access to posted lecture files for either 72hours or the entire semester did not correlate to improved coursegrades or have an impact on class attendance. The routine use oflecture-capture devices may not be as important as students perceive.

77. Economic evaluation of clinical interventions from anintegrated internal medicine and ambulatory care APPE. MichaelJ. Gonyeau, BPharm, Pharm.D., BCPS1, Maureen McQueeney,Pharm.D., BCPS, CDE2; (1)Northeastern University School ofPharmacy/Brigham and Women’s Hospital, Boston, MA;(2)Northeastern Univeristy School of Pharmacy/Brigham andWomen’s Hospital, Boston, MA PURPOSE: Most APPEs occur from 4–6 weeks, a narrow windowfor students to feel comfortable and confident before moving on,affecting their ability to accurately and completely document clinicalinterventions. Our objective was to conduct an economic analysis ofclinical interventions documented during an integrated 12 week APPEmodel compared to previous non-integrated APPE data and to quantifyvalue added to students, preceptors and institutions. METHODS: A 6 week ambulatory care (AC) and internal medicine(IM) APPE were integrated into a longitudinal 12 week APPEcomprised of a fluid structure where students transitioned frominpatient to outpatient services multiple times with increased studentexposure to patients transitioning from inpatient to outpatient care.Clinical intervention documentation was required via a web-basedsystem and data from the integrated APPE was compared to previousstudents from each preceptor from stand-alone AC and IM rotations atthe same hospital. Specific comparisons included adverse drug events(ADEs) and medication errors (MEs) prevented, as well as aneconomic evaluation to evaluate cost savings. RESULTS: Twelve integrated APPE students documented 1984interventions vs. 873 from 12 students completing separate APPEswith the same preceptors (p <0.001). Intervention categories remainedconsistent with a significant increase in medication historiesperformed (11.5% to 18.3%) and level of significance increased in theintegrated model. 1053 ADEs were prevented (936 integrated vs. 117pre-integration, p<0.001) associated with a total cost savings of$332,985. Similarly, 274 MEs were prevented (168 integrated vs. 108pre-integration, p=0.07) associated with a cost savings of $34,012.This averages $26,403 cost savings per student in the integrated modelvs. $4086 pre-integration (p<0.001) over a 12-week period. CONCLUSION: An integrated APPE decreases orientation time forstudents and preceptors, increases patient interaction, increasesclinical intervention documentation and increased prevention of ADEsand MEs, resulting in increased institutional cost savings.

78. Communication of clinical recommendations during patientcase-based cardiovascular therapeutics oral examinations. Lisa M.Lundquist, Pharm.D., BCPS, Angela O. Shogbon, Pharm.D., BCPS,Kathryn M. Momary, Pharm.D.; Mercer University College ofPharmacy and Health Sciences, Atlanta, GA PURPOSE: To compare students’ self-assessment and facultyevaluation of communication of clinical recommendations duringtherapeutics oral examinations. METHODS: For two consecutive years in the Cardiovascular / Renal


therapeutics course, one individual and one group patient case-basedoral examination were given to all second-year pharmacy students.Students were provided with patient cases prior to each oralexamination. In addition to evaluation of pharmacotherapyknowledge, faculty evaluated students’ communication skills using ascoring rubric divided into two areas: rapport (confidence, non-verbal)and presentation of therapeutic recommendations (concise,pronunciation, well-prepared). Faculty evaluated these skills on a 4-point Likert scale with 1=needs significant development and4=accomplished. Immediately following each oral examination,students self-assessed their communication skills using the samerubric. This study was approved by the IRB and students voluntarilysigned informed consent prior to participation. Students’ self-assessments were compared to faculty evaluation of theircommunication skills using descriptive statistics and paired t-tests. RESULTS: A total of 261 (96.3%) students completedcommunication self-assessments following each oral examination. Forthe individual oral examination, mean(SD) student self-assessmentand faculty’s evaluation of communication were 3.27 (0.49) and 3.50(0.41) year one; 2.98 (0.54) and 3.46 (0.47) year two. For the grouporal examination, mean(SD) student self-assessment and faculty’sevaluation of communication were 3.41 (0.49) and 3.60 (0.31) yearone; 3.20 (0.45) and 3.60(0.37) year two. Faculty evaluations in boththe individual and group oral examinations were statisticallysignificantly higher than the students’ self-assessments in both years(p<0.001). In addition, in both years, students’ self-assessment ofcommunication increased from the individual to the groupexamination (p<0.001). CONCLUSION: Students’ self-assessment of communication skillswere consistently lower than the faculty’s evaluation scores. Students’lower self-assessment may be due to a lack of practice in the verbalcommunication of clinical recommendations. Greater utilization offormal case-based oral examinations may help to improve student’sconfidence and self-assessment of their communication skills.

79. The process of assessing student performance; is creating arubric the answer?. Jayne E. Lepage, Pharm.D., Abir O. Kanaan,Pharm.D., Jennifer L. Donovan, Pharm.D.; Massachusetts College ofPharmacy and Health Sciences, Worcester, MA PURPOSE: To comply with the Accreditation Council for PharmacyEducation (ACPE) assessment requirements in experiential education,a standardized rubric that includes formative and summative criteriawas created to assess student performance and the experientialcomponent of the curriculum. The purpose is to describe this processand to share the tool that was created. METHODS: A faculty task force comprised of various pharmacypractice specialists and representatives from the Department ofExperiential Education was assembled and charged with thedevelopment of a standardized evaluation rubric that would be utilizedacross all types of advanced pharmacy practice experiences (APPE)and that would facilitate assessment of the experiential component ofthe curriculum. A rubric was developed based on national practiceguidelines published by the American College of Clinical Pharmacyand the school’s student learning outcomes derived from the ACPEstandards. RESULTS: Rubrics were created and included criteria that assessed astudent knowledge, skills and attitude within a particular activityoutcome. The rubrics were then piloted by a subset of faculty, selectadjunct faculty and students. A 5-item survey was administered atspecific time periods throughout the APPE rotations to assess thecontent and applicability within each performance criteria, and thecorrelation between student performance, specified competencies, andgrading criteria. Subsequently, adjustments were made to clarify theperformance criteria and through this process a universal rubric wascreated. Since the rubric is based on ACPE standards and the school’sstudent learning outcomes, a smooth transition for assessment ofstudent performance and the experiential curriculum may now occur. CONCLUSION: A systematic process that was faculty drivenallowed for a standardized rubric to be created which will facilitateassessment of student performance and of the experiential componentof the curriculum.

80. Current state of teaching oncology pharmacotherapy: focus on

cancer as a chronic disease. Michael Newton, Pharm.D., BCOP1,Myke Green, Pharm.D., BCOP2, Christopher Campen, Pharm.D.,BCPS2, Terry Schwinghammer, Pharm.D., BCPS1; (1)Department ofClinical Pharmacy, West Virginia University School of Pharmacy,Morgantown, WV; (2)Department of Hematology and MedicalOncology, Arizona Cancer Center, Tucson, AZ PURPOSE: The rapidly changing face of oncology pharmacotherapyrepresents a challenge in pharmacy education. Cancer accounts fornearly 25% of all deaths in the United States and will likely exceedheart disease as the number one cause of death in the near future.Pharmacotherapy options for patients with cancer are expandingrapidly and include many oral agents with novel mechanisms ofaction. While oncology has traditionally been the realm of specialists,the ability to manage many cancers as chronic diseases has movedanticancer treatment into mainstream pharmacy practice. The goal ofthis report is to examine how U.S. schools and colleges of pharmacyaddress oncology pharmacotherapy. METHODS: A survey of pharmacy practice department chairs atschools and colleges of pharmacy in the United States was conductedusing a 20-question survey instrument. The instrument capturedoncology teaching methods, oncology pathophysiology andpharmacotherapy contact hours, education and background ofinstructors, and personal opinions regarding importance of oncologyin the professional pharmacy curriculum. RESULTS: Seventy-two (62%) of the 116 institutions responded. Amedian number of 28 contact hours were reported for oncologypharmacotherapy (range: 8–108 hours). Two-thirds of respondentsreporting below 28 contact hours expressed no need to dedicate moretime to oncology pharmacotherapy. About 60% of schools employboard-certified oncology specialists, but about 20% employ facultywithout oncology expertise. Pharmacogenomics information isintegrated into applicable pharmacotherapy lectures at 58% ofresponding schools. Ten percent of schools either do not teachpharmacogenomics or are currently evaluating how to best incorporateit into their curriculum. CONCLUSIONS: These survey results provide insight to schools andcolleges of pharmacy to help ensure that all pharmacists havesufficient training in oncology to provide competent care to patientswith cancer.

81E. Using standardized colleagues to develop interprofessionalcommunication skills. Susan Meyer, Ph.D.1, Hollis Day, M.D.2, HelenBurns, Ph.D.3; (1)University of Pittsburgh School of Pharmacy,Pittsburgh, PA; (2)University of Pittsburgh School of Medicine,Pittsburgh, PA; (3)Excela Health, Greensburg, PA PURPOSE: Interprofessional communication is a critical element topatient care. This study compared two methods of teaching pharmacystudents how to communicate with physicians in challengingscenarios: standardized colleagues (adaptation of standardizedpatients) and video triggers/group discussions. METHODS: In spring 2010, 57 students interacted with medicalfaculty as standardized colleagues portraying particular professionalroles, attitudes, and communication styles. Pharmacy and medicalfaculty provided feedback on demonstrated behaviors impactingcommunication effectiveness. Forty-seven (47) students viewedvideos demonstrating interprofessional interactions and participated infacilitated discussions of the demonstrated interprofessionalcommunication skills. A self-evaluation of comfort and confidence incommunication skills adapted from a validated instrument wasadministered at baseline, three, and six months. Students completed anevaluation of the perceived helpfulness of the activity. Data fromstudents with scores on all three time points were used in the analysis(n=92) using paired samples t-tests. An independent samples t-test wasperformed to determine differences in mean scores for the activities.The activity was repeated in spring 2011. Analysis focused on studentperceptions of the teaching strategy for the purposes of improvinginterprofessional communication skills. RESULTS: Results of the repeated measures ANOVA demonstratedan increase in comfort and confidence over time (F=42.508, = 2,p<0.001). Paired samples t-tests showed a significant increasebetween baseline and three months (t =-7.615, 99, p<0.001). Anindependent samples t-test revealed a significant difference inhelpfulness, confidence, and comfort between the video and

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standardized colleagues methods (t=-2.396, 82.69, p=0.019). Studentfeedback regarding the standardized colleague teaching strategy wasoverwhelmingly positive. CONCLUSIONS: Using standardized colleagues can enhancestudents’ abilities to communicate effectively in challengingsituations.Presented at Collaborating Across Borders III, Tucson, AZ, November19–21, 2011.

82. Student Perceptions of Large Scale InterprofessionalEducation Events. John E. Murphy, Pharm.D.1, Lynne Tomasa,Ph.D.2, Andreas Theodorou, M.D.2, Cathleen Michaels, Ph.D., RN3,Nancy Coleman, B.S.2, Doug Taren, Ph.D.4; (1)The University ofArizona College of Pharmacy, Tucson, AZ; (2)The University ofArizona College of Medicine, Tucson, AZ; (3)The University ofArizona College of Nursing, Tucson, AZ; (4)The University ofArizona College of Public Health, Tucson, AZ PURPOSE: The Interprofessional Education Collaborative recentlyreleased its “Core Competencies for Interprofessional CollaborativePractice.” Interprofessional Education (IPE) events at the Universityof Arizona Health Sciences Center have been designed to developmany of these competencies over the last six years. Studentevaluations of the value of the events were collected and used toenhance future events. METHODS: IPE events on communication and culture, disabilities,team behavior during cardiopulmonary resuscitation, and pandemicinfluenza were conducted for students from medicine, nursing,pharmacy, public health, and, in some cases, law and social work. Thenumber of participants ranged from ~300 to 450 per event.Participants completed either a paper or online evaluation after eachevent. A consistent set of questions as well as questions specific toeach event were used. Students also provided comments on what theyliked and disliked. RESULTS: All sessions led to improvements in student perceptionsof their knowledge of the topics covered and understanding of thevalue of teamwork based on their before and after assessment. Forexample, pharmacy students rated their understanding of disruptivebehaviors and the impact on teamwork as somewhat high or highbefore (69%) and after (100%) the activity. Occasionally there weredifferences in ratings based on profession, but these tended to be fairlysmall. Student comments tended to be constructive and targetedtowards improvement. Occasionally students’ complained that somemembers of small group discussions didn’t participate well or thattheir time should be spent studying. CONCLUSION: The IPE events were generally rated well bystudents across the professions. Before and after comparisons showedincreased understanding of the issues covered in the sessions andstudents had greater appreciation of the importance of workingtogether as an effective team. Further research should focus onwhether such programs lead to better teamwork in practice.

83. Evaluation of pharmacy students’ clinical interventions andestimated cost avoidance during a general medicine rotation.Daniel R. Stevens, B.S.1, Adam B. Woolley, Pharm.D., BCPS2,Michael T. Brennan, Pharm.D.3; (1)Northeastern University, Boston,MA; (2)Northeastern University Department of Pharmacy Practice,Boston, MA; (3)VA Boston Healthcare System, West Roxbury, MA PURPOSE: To determine the estimated institutional cost avoidanceresulting from pharmacy student interventions during an internalmedicine rotation at an academic teaching hospital. METHODS: Quantifi® is a clinical intervention database toolutilized by both pharmacists and pharmacy students. Fourth-yearprofessional (P4) students were asked to document all interventionsperformed while completing their six-week general medicineAdvanced Pharmacy Practice Experience (APPE). Quantifi® wasretrospectively reviewed for interventions recorded by 17 studentsduring a 36-week period between August 2010 and June 2011.Interventions were then evaluated by associated cost avoidanceestimated by the intervention system, intervention category, and drugclass. RESULTS: A total of 727 interventions were recorded over the courseof the study period. The Quantifi® algorithm generated an estimatedtotal cost avoidance of $55,879. The most common intervention

categories reported were dose evaluations (11.4%), recommendationfor medication change or addition (10.3%), and medicationreconciliation (8.7%). The intervention categories associated with thegreatest cost avoidance were dose evaluation ($12,393), warfarindosing ($5,355), and insulin dose titration ($4,437). A total of 198unique medications were cited in the interventions. The four mostcommonly documented medications accounted for 29.9% of totalinterventions, and were associated with the most significant costavoidance: warfarin ($8,274), vancomycin ($5,894), insulin ($5,126),and heparin ($1,866). CONCLUSION: Fourth-year professional Doctor of Pharmacystudents on APPEs represent a valuable resource to academic teachinghospitals and have the potential to make a significant contribution tooverall cost avoidance and patient care.

84. Knowledge and attitude of clinical pharmacy faculty towards,and issues related to behind-the-counter drug program. VishalBali, M.S., Digvijay Yeola, M.B.A., Sujit S. Sansgiry, Ph.D.;Department of Clinical Sciences and Administration, College ofPharmacy, University of Houston, Houston, TX PURPOSE: Clinical pharmacy faculty members provide informationand train pharmacy student’s on Behind The Counter (BTC) drugs.The objective of this study was to determine knowledge and attitudeof clinical pharmacy faculty towards, and issues related to BTC drugprogram. This study helps to identify factors that need to be addressedto develop and implement a strong BTC drug program. METHODS: A prospective cross-sectional study using an onlinesurvey was conducted. Six hundred fifty clinical pharmacy facultymembers from different practice settings were randomly selected foran electronic survey and responses were collected anonymously byusing QualtricsTM. Knowledge and attitude of clinical pharmacyfaculty were measured using previously validated scales adapted toour study. Data on respondent characteristics, and issues concerningBTC drug program were also collected. We hypothesized that clinicalpharmacy faculty would have good knowledge and positive attitudetowards BTC drug program. Statistical analyses were performed usingSAS statistical package.RESULTS: A total of 128 completed responses were received (20%response rate). Majority of participants (85%) were found to have fairknowledge regarding the BTC drug program (53.20%). Most (91%)felt the need for BTC drug program, and indicated that such a programwould increase patient safety (81%). Respondents supported the needfor private counseling areas within the pharmacy (93%), adequatecounseling fee (87%), and proper reimbursement provisions (97%) forimplementing a good BTC drug program. Sixty five percent of theparticipants agreed that pharmacy students should be trained toprescribe and dispense BTC drugs. CONCLUSION: Clinical pharmacy faculty members had fairknowledge and positive attitude towards the BTC drug program. Theyneed to improve their knowledge about BTC drug program so as tobetter train pharmacy students in providing BTC drug services.Considerations may be needed in evaluating pharmacy design andreimbursement provisions for BTC programs.

85. Faculty development activities in US pharmacy schools. HolleyRice, Pharm.D., Michael G. Kendrach, Pharm.D., B.S.Pharm.,FASHP; McWhorter School of Pharmacy, Birmingham, AL PURPOSE: Survey US schools of pharmacy to identify their facultydevelopment program (FDP) content and requirements. Literaturedescribing faculty development within health sciences has beenpublished. However, specific information addressing pharmacy FDP islimited and FDP details from schools of pharmacy (SoRx) have notbeen published recently. METHODS: An online survey consisting of 21 multiple-choice and 2short-answer questions was created (surveymonkey.com) andreviewed by three school of pharmacy faculty. The Academic Deansof 106 US SoRx were identified via the American Association ofColleges of Pharmacy (AACP) website and sent an email requestingthe best person at the SoRx to complete the survey. SamfordUniversity IRB approved this research. RESULTS: A total of 38 surveys (35.8%) were completed with anequal number of responders from private and public SoRx. Whilemany (71%) SoRx have a formalized FDP, 55.3% do not require


faculty to complete FDP activities, only 31.6% have a highlyindividualized FDP for each faculty that is approved by the SoRx, and44.7% of faculty complete FDP activities at their own discretionwithout any oversight by SoRx. Although 55.3% include FDPactivities in annual performance reviews, 65.8% do not factor FDPaccomplishments in annual merit pay raises and most faculty do notwant FDP part of the annual performance review. Few (34.2%) SoRxhave assessed their FDP. The primary FDP activities (≥ 90% ofresponders) are scholarship/publications, teaching/pedagogy, activelearning methods, test writing skills, and technology. CONCLUSION: FDP are common at US SoRx, but faculty are notrequired to participate and many are not tailored to individual facultyneeds. A formalized FDP should be established at each SoRx that iscontinually evolving and enables faculty to improve and fulfill thecurrent requirements and definition of a faculty member. These datacan be used in developing the SoRx FDP.

86. Pre-pharmacy biomedical literature experience: a survey ofpharmacy student self-perception and ability to identify literaturetypes. Valerie A. Coppenrath, Pharm.D., Evan R. Horton, Pharm.D.,Kimberly A. Pesaturo, Pharm.D.; Massachusetts College of Pharmacyand Health Sciences, Worcester, MA PURPOSE: The purpose of this study is to characterize previousexperiences with biomedical literature of students entering their firstyear of an accelerated doctor of pharmacy program. METHODS: The primary objective of this study was to determine ifcorrelations existed between student self-assessment of knowledgeregarding sources of biomedical literature and ability to identifyspecific literature types. The secondary objective was to characterizestudents’ previous experience with biomedical literature. A 17-question survey was distributed to 280 first-year pharmacy students atorientation. Participants were asked to indicate if they understooddifferences between primary, secondary, and tertiary literature, andwere then asked to demonstrate understanding using three multiplechoice questions. Participants who correctly responded to all threemultiple choice assessment questions were considered “able toidentify types of biomedical literature.” Additionally, participantsreported on previous biomedical literature experience. RESULTS: Two hundred and forty-nine students completed thesurvey, and 237 students responded to the survey item regardingunderstanding differences between primary, secondary, and tertiaryliterature. One hundred thirty-seven participants (57.8%) indicatedunderstanding, while 100 participants (42.2%) indicated non-understanding. Of the 137 students who indicated understanding, 19students (13.9%) correctly identified types of biomedical literature; ofthe 100 students who reported non-understanding, 8 students (8%)correctly identified types of biomedical literature (OR 1.85, 95% CI0.78 to 4.42). Two hundred and sixteen (86.7%) participants reportedpreviously having been asked to read biomedical literature in theiracademic career. CONCLUSION: Students reporting an understanding of thedifference in literature types were no more likely to correctly identifyliterature types when compared to participants who reported notunderstanding. Students entering the accelerated Doctor of Pharmacydegree program reported varying degrees of instruction and exposurerelated to biomedical literature. Faculty teaching courses related tobiomedical literature may consider these findings when developingcourse content.

87. Pharmacy student knowledge retention after completing asimulation utilizing high-fidelity mannequins compared to awritten patient case. Douglas Wylie, Pharm.D.1, Shaunta’ Ray,Pharm.D., BCPS2, Andrea S. Franks, Pharm.D., BCPS2, A. ShaunRowe, Pharm.D., BCPS2; (1)The University of Tennessee MedicalCenter, Knoxville, TN; (2)The University of Tennessee College ofPharmacy, Knoxville, TN PURPOSE: To determine if participation in a simulated patient caseimproves knowledge retention and students’ comfort level whencompared to a written case. METHODS: This was an IRB exempt, parallel group, randomizedcontrolled trial. Students were randomized to either a simulationmannequin scenario or written patient case. The case involved theidentification, triage and treatment of an oxycodone and

acetaminophen overdose. Students were administered a multiple-choice test and a survey assessing the students’ comfort before thecase, immediately after the case, and twenty-five days later. RESULTS: Twenty-six students were included in the study. Therewas no difference in knowledge retention or comfort level between thegroups. A statistical difference was seen in test scores whencomparing pretest to posttest, p<0.01. Participation in a simulatedpatient case did not improve knowledge retention or comfort with thematerial when compared to traditional patient cases. CONCLUSION: Though no statistical differences were seen in themannequin group vs. written patient case group, both instructionmethods effectively improved knowledge retention.

88. Evaluating the impact of implementing pharmacy cardiologyrounds on student exam performance in a pharmacotherapeuticscourse. Fae Wooding, Pharm.D.1, Michael Steinberg, Pharm.D.1,Kristine C. Willett, Pharm.D.2, Jennifer L. Donovan, Pharm.D.1, AbirO. Kanaan, Pharm.D.1; (1)Massachusetts College of Pharmacy andHealth Sciences, Worcester, MA; (2)Massachusetts College ofPharmacy and Health Sciences, Manchester, NH PURPOSE: Historical examination performance of students in ourPharmacotherapeutics course has indicated the cardiology module ischallenging to students in our accelerated Doctor of PharmacyProgram. This course, which is taught utilizing distance education, isfacilitated with a learner-centered, active-learning, case-basedapproach. Pharmacy cardiology rounds were incorporated to providestudents an opportunity to further review and apply their conceptualknowledge prior to exams. The purpose of this study is to evaluate theimpact of pharmacy cardiology rounds on student exam performance. METHODS: Instructors submitted questions that were formatted intoa faculty member-facilitated question and answer session held 2 daysprior to the scheduled exam. During the cardiology rounds session,instructors proffered cardiology-related clinical scenarios andquestions based on material from previous classes and self-studypackets. Student attendance for the session was documented using theTurningPoint response system. Mean exam scores were calculated forstudents that attended cardiology rounds (attendees) and compared tothose who did not attend (absentees). The scores were also evaluatedwithin each of our two campuses. A two tailed-test was used toanalyze the data for statistical significance of any differencesidentified. RESULTS: A total of 166 students attended cardiology rounds. Themean exam score for attendees was 77.5% compared to 71.7% forabsentees (P<0.001). Mean scores of attendees on the local campusperformed better than absentees (77.4% vs. 72.0%; P<0.001). Asignificant difference was not observed on the distance campus(attendees, 77.7% vs. absentees, 70.0%; P=0.09318). CONCLUSION: Students who attended cardiology rounds performedsignificantly better on subsequent examination compared to studentswho did not attend the sessions. Inclusion of a similar pharmacyrounds should be considered for other pharmacotherapeutic modules.

89E. Development and evaluation of a rubric to assess value ofstudent WIKI contributions. Bonnie A. Falcione, Pharm.D., BCPS,Denise L. Howrie, Pharm.D., Susan M. Meyer, Ph.D.; University ofPittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: Available quantitative assessment tools may notsufficiently measure individual student performance on WIKI-basedgroup activities. This study aimed to develop and evaluate a rubric toassess the value of an individual student’s contributions to WIKI-based collaborative cased-based group work. METHODS: A rubric to assess “value” of individual student’s WIKIcontributions was developed and tested during a collaborative case-based activity in a pharmacotherapy course. Independent rubricapplication by two faculty members to 10 randomly selected student’swork indicated initial reliability. A revised rubric was applied to thework of 30 randomly selected students. Faculty reviewed and scoredeach contribution with the rubric then assigned an “Overall Value’’ foreach student. A Composite Score was calculated for each student fromweighted contribution scores. Reliability of these measures andcorrelation with available quantitative assessment measures of studentperformance was evaluated with Spearman’s Rank and PearsonCorrelation.

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RESULTS: A rubric modeled upon Bloom’s Taxonomy with a 4-pointvalue scale and six domains was created to evaluate student WIKIcontributions. Comparison of the 30 student Overall Value scoresdemonstrated 66.7% rater concordance and moderate inter-raterreliability (k=0.428, SE=0.143; p=0.003, 95%CI=0.148-0.707). Astrong correlation was found for the raters’ assigned Overall Values(r=0.603, p<0.001), the calculated Composite Scores (r=0.731,p<0.001) and these measures were also well correlated (r=0.421,p=0.023). A weak negative correlation was found for Composite Scoreand pages saved (r=-0.163, p=0.40), group grade (r= 10.153, p=0.42),and peer evaluations (r=-0.106, p=0.58). Faculty spent a median of6–10 minutes (IQ range 6–15min) to evaluate a student’s total WIKIcontributions. CONCLUSION: This unique Bloom’s Taxonomy based WIKI rubricgenerated moderately reliable measures of individual student WIKIcontributions to group work. A WIKI rubric may provide a betterassessment of individual student performance than existing methods. Published in Am J Pharm Educ. 2010 June 15;74(5):96

Emergency Medicine

90. The combination of Prothrombin Complex Concentrate,Factor VIIa, and Phytonadione to reverse elevated internationalnormalized ratio. Bryce J. Bitton, Pharm.D., Kevin P. Myers,Pharm.D., C. Dustin Waters, Pharm.D.; McKay-Dee Hospital, Ogden,UT PURPOSE: Little dosing consensus exists for clotting factorreplacement in patients with elevated international normalized ratio(INR). This study analyzes the efficacy, dosing, and thrombogenicityof the combination of Prothrombin Complex Concentrate (PCC),Factor VIIa, and Phytonadione for lowering INR. METHODS: Medical records of the 22 total protocol doses givenwere reviewed to assess dosage, baseline INR, resulting INR, andincidence of thromboembolism. Patients with an initial INR of 1.5-4.0received PCC 25 units/kg Ideal Body Weight (IBW) and those with anINR > 4.0 received PCC 50 units/kg IBW (all PCC doses rounded tothe nearest vial size). All patients received Factor VIIa 1 mg andPhytonadione 5–10 mg IV. RESULTS: The protocol reduced INR to ≤ 1.3 in patients with aninitial INR ≥ 1.5 (range 1.5-13.2) in 100% of cases. The mean baselineINR was 3.4 and resulting INR was 0.9. Fourteen patients (64%) had aresulting INR < 1. The mean PCC dose was 1938 units (28.6 units/kgIBW) for patients with an INR 1.5-4.0 and 2765 units (36 units/kgIBW) for patients with INR > 4.0. Thromboembolism occurred in 4patients (18%). CONCLUSION: The protocol is effective at quickly lowering INR inpatients with an elevated INR. Dosing PCC based on INR and IBWappears to be appropriate. Thromboembolism is a genuine concernwhen giving clotting factor replacement. Based on the effectiveness ofthis protocol at lowering INR, the number of patients with a resultingINR < 1, and the cases of thromboembolism, further INR stratificationand lower PCC doses should be considered.

91. Retrospective Review of NPO Status in Children ReceivingKetamine for Procedural Sedation in the Emergency Department.Megan E. Foster, Pharm.D.; Le Bonheur Children’s Medical Center,Department of Pharmacy, Memphis, TN PURPOSE: Guidelines for moderate sedation recommend fastingfrom liquids for two hours and solid food for eight hours. Strictadherence to these guidelines is difficult in the emergency department(ED). Recent studies have demonstrated no association betweenfasting times and adverse events. Our purpose is to evaluate pre-procedural fasting times and identify any adverse effects. METHODS: We conducted an 18-month retrospective review ofNPO status in patients who received procedural sedation in the EDfrom January 2010 to June 2011. Patients who received ketamine wereidentified utilizing computerized physician order entry (CPOE) andelectronic medical record (EMR) data. Patients were excluded ifsedation occurred in the operating room (OR), or if NPO status wasnot documented. NPO status and any adverse events that occurredwere assessed to determine what our current practice entails. RESULTS: A total of 318 patients were identified, of which 10 wereexcluded due to receiving sedation in the OR. Of the 308 included

patients, NPO status was attainable by chart review in all patients.Patients ranged from 18 months to 17 years of age. Overall, 95% ofpatients sedated were by conservative NPO guidelines. Physicianswho followed last liquid intake leaned towards waiting 4 hours versusthe recommended 2 hours, whereas time from last solid food intakeremained at 8 hours. In addition, 77% of procedural sedationsoccurred between 2000 and 0800, indicating a pattern in followingconventional NPO guidelines, based on midday and evening meals.Nausea or vomiting occurred in 4% of patients, however all patientswere 8 hours past their last oral intake. CONCLUSION: Our ED physicians practice in accordance withtraditional NPO guidelines. Further evaluation is needed to determinethis impact on length of stay, staffing, and patient safety. Currentguidelines should be re-evaluated based on recent literature supportfor reduced NPO times.

92. Incidence and characteristics of antithrombotic errors in theemergency department. Aaron J. Prince, Pharm.D.1, Stephen Rolfe,Pharm.D., BCPS2, Jeffrey Dandurand, Pharm.D., BCPS3, Kimberly A.Pesaturo, Pharm.D., BCPS4; (1)UMass Memorial Medical Center,Worcester, MA; (2)University of New England, College of Pharmacy,Portland, ME; (3)Clinical Pharmacy Associates, Laural, MD;(4)Massachusetts College of Pharmacy and Health Sciences -Worcester/Manchester, Worcester, MA PURPOSE: The goal of this study was to identify and characterizethe incidence of antithrombotic errors by review of patients’ medicalrecords in an emergency department (ED) at a large academic medicalcenter. METHODS: All patients admitted to the emergency departmentbetween January 2010 and April 2010 with an order for one or moreantithrombotic agents were considered for inclusion. An independentpharmacist abstracted demographic and medication-related data fromthe medical record for included patients. Next, two independentpharmacists evaluated the abstracted data for the presence ofmedication errors. If consensus was not reached between the twopharmacists, a third pharmacist was utilized to determine if an errorwas present. The primary endpoint was to determine the incidence ofantithrombotic-related medication errors that occur in the ED.Secondary endpoints included categorization of errors by stage in themedication use process and by severity according to the NCC-MERPalgorithm. RESULTS: Of the 1550 antithrombotic orders identified, 957 metinclusion criteria, of which 432 were evaluated. Errors were present in22.7% of the orders, most commonly occurring with heparin (46.5%),enoxaparin (28.1%), and warfarin (18.4%). The majority of errors(84.2%) transpired during the prescribing and ordering stage of themedication use process. Errors reached the patient 79.8% of the timewith 14.3% experiencing temporary harm which required additionalmonitoring or medical intervention. Additionally, the most commonsources or error were under-dosing, improper date and timedocumentation, no base line INR, and over-dosing. Lack of obtaininga patient’s weight contributed to 32.7% of the orders written in error. CONCLUSION: Errors were identified in over one-fifth ofantithrombotic orders in the ED over the four-month study period. Themajority of errors identified occurred during the prescribing andordering stage. The majority of identified errors reached the patient,however only a small subset required intervention.

93. Intranasal Fentanyl and Midazolam Use in a PediatricEmergency Department. Megan E. Foster, Pharm.D.; Le BonheurChildren’s Medical Center, Department of Pharmacy, Memphis, TN PURPOSE: Intranasal medication delivery is a fast and effectiveadministration route, particularly in the emergency department (ED).Our ED recently implemented intranasal use of fentanyl andmidazolam for short term procedures. This review identifiesindications for intranasal medication use, dosing ranges, and anyadverse effects observed. METHODS: Patients who received nasal fentanyl or midazolam inthe ED between April 1st–June 1st, 2011 were identified utilizingcomputerized physician order entry (CPOE) and electronic medicalrecord (EMR) data. Patient age, indication for medication, doseranges, adverse effects, and discharge status were evaluated. ED staffsatisfaction and patient and family satisfaction with nasal medication


delivery versus alternative methods were evaluated throughanonymous surveys. RESULTS: A total of 102 patients were identified during the 2-monthstudy period. The most common indications for intranasal medicationdelivery were abscess incision and drainage, laceration repair, andintravenous (IV) access and foley catheter insert. Several patientsreceived pain control or anxiolysis with intranasal medication beforeIV access could be attained. Midazolam demonstrated to be mosteffective at 0.2–0.5 mg/kg/dose and fentanyl at 2–4 µg/kg/dose.Adverse effects included rash in one patient, which resolved with oraldiphenhydramine, and paradoxical agitation to midazolam in onepatient, which resolved with no intervention. The majority of patientswere discharged home with no complications and positiveexperiences, according to ED staff, patient, and family satisfactionsurveys. CONCLUSION: Intranasal fentanyl and midazolam areadvantageous alternatives to oral or intramuscular (IM) pain oranxiolysis medications, particularly in the ED. With a fast onset andshort duration of action, many short procedures or exams can beperformed effectively and quickly without waiting for oral or IMmedication onset of action. Further medications should be evaluatedfor intranasal use in the ED.

Endocrinology

94. Utilization of home telehealth monitoring with activemedication management by clinical pharmacists in poorlycontrolled diabetic patients. Kristen J. Davis, Pharm.D.1, Jessica L.Wallace, Pharm.D.1, Jim Wan, PhD2, M. Shawn McFarland,Pharm.D.1; (1)Veterans Affairs Tennessee Valley Healthcare System,Nashville, TN; (2)University of Tennessee Health Sciences Center,Memphis, TN PURPOSE: This study assessed the change from baseline in A1Cover 6 months in a cohort of diabetic patients through medicationmanagement performed by a clinical pharmacy specialist (CPS) withtelehealth intervention compared to a cohort without telehealthintervention. The percentage of patients meeting American DiabetesAssociation (ADA) treatment goals for A1C, amount of time spent,and the number of diabetic medication changes made were assessed. METHODS: Records were reviewed in 103 type 2 diabetics oninsulin therapy with an A1c >7% seen by a CPS between October 1,2008 and April 1, 2010, and with two follow-up visits with the CPS.Patients were divided into those enrolled in telehealth versus thosewho were not. The A1c values at baseline, three and six months (±45days) were documented as were the number of non face-to-faceencounters and diabetic medication changes made by the CPS. RESULTS: Baseline demographics were similar between groups withan initial A1c of 9% and 9.1% in the telehealth (n=36) and controlgroups (n=67), respectively (p=0.621). Telehealth versus controlpatients demonstrated a significant difference in mean A1c at three(7.2% vs. 8.0%, p=0.0002) and six months (6.9% vs. 7.5%, p=0.0066).The mean reduction in A1c from baseline to six months was notsignificant (p=0.1987). 69% of the telehealth group vs. 36% of thecontrol group achieved the A1c goal of less than 7% (p=0.0011). Moretime was spent (p<0.001) and more diabetic medication changes weremade (p<0.0001) in the telehealth group. CONCLUSION: Management of diabetic patients on insulin may beoptimized via CPS utilization of telehealth. Though no statisticallysignificant difference was seen regarding mean change in A1c frombaseline to six months, telehealth intervention did show significantdifferences in A1c at three and six months coupled with higherachievement of ADA A1c goals after six months.

95E. Trends in hyponatremia management and associatedoutcomes in hospital settings: Interim results from anobservational, prospective, multi-center, global registry inhospitalized patients. Joseph Dasta, M.S., R.Ph.1, Alpesh Amin,M.D.2, Jun Chiong, M.D.3, Arthur Greenberg, M.D.4, Paul Hauptman,M.D.5, Joseph G. Verbalis, M.D.6; (1)College of Pharmacy, The OhioState University, Columbus, OH; (2)UC Irvine College of Medicine,Irvine, CA; (3)Loma Linda University, Loma Linda, CA; (4)DukeUniversity Medical Center, Durham, NC; (5)St. Louis UniversitySchool of Medicine, St. Louis, MO; (6)Georgetown University

Medical Center, Washington, DC PURPOSE: Although hyponatremia (HN) is the most commonelectrolyte abnormality in hospitalized patients, little is knownregarding the influence of HN and its management on patientoutcomes and healthcare resource usage. The HN Registry is a novelprospective effort to document the clinical and healthcare outcomes ofHN and its management. The first 25 HN patients enrolled aredescribed here. METHODS: After informed consent or waiver, data were extractedfrom medical charts of enrolled patients. HN was defined as a serumsodium ≤ 130 mmol/L. The pilot data were summarized appropriatelyby sample size and for categorical data by percentage. Subjects whohad HN on admission were categorized as pre-existing HN patientsand those who were admitted for another reason and developed HNwhile in the hospital were categorized as hospital-acquired HNpatients. RESULTS: Overall, only 20% of the enrolled patients received anypharmacologic management for HN and approximately 44% weredischarged with persistent HN (21% of treated vs. 79% of untreated).Among the patients discharged with HN, 55% had a previous episodeof HN. In addition, among the patients with previous HN, 46% weredischarged with persistent HN. The length of stay for patients withpre-existing HN was 1.3 days longer compared to patients withhospital-acquired HN. These findings will be further evaluated andreported as more data in this large registry study are accumulated. CONCLUSION: Among hospitalized patients, HN is frequentlyuntreated, and nearly half of patients are discharged withoutnormalization of serum sodium. HN commonly persists throughseveral hospital admissions. Presented at Presented at the International Society forPharmacoeconomics and Outcomes Research meeting, Baltimore,MD, May 22–25

96E. Dapagliflozin Monotherapy and Combination TherapyReduces Hyperglycemia in Patients with Type 2 Diabetes. John R.White Jr., Pharm.D., PA-C1, Arnaud Bastien, M.D.2, Shamik Parikh,M.D.3, Veronika Hruba, M.D.4, Afshin Salsali, M.D.2, Lisa Ying,Ph.D.2, Jennifer Sugg, M.S.3, James F. List, M.D., Ph.D.2;(1)Washington State University, Spokane, WA; (2)Bristol-MyersSquibb, Princeton, NJ; (3)AstraZeneca, Wilmington, DE;(4)AstraZeneca, Prague, Czech Republic PURPOSE: Dapagliflozin (DAPA), a selective inhibitor of the renalsodium-glucose co-transporter 2, reduces excess plasma glucoseindependently of insulin secretion or action, by inhibiting renalglucose reabsorption, thereby increasing glucose excretion. Efficacyand safety data were analyzed from METHODS: Patients were treated with DAPA 2.5, 5, or 10 mg orplacebo once daily for 24 weeks as monotherapy in drug-naïvepatients (Study 1, NCT00528372, N=485 [main cohort n=274]), asadd-on therapy to GLIM (Study 2, NCT00680745, N=596), or as add-on therapy to MET (Study 3, NCT00528879, N=546). The primary RESULTS: DAPA significantlyCONCLUSIONS: Dapagliflozin significantly improved glycemiccontrol and reduced body weight, and Presented at Presented at the Annual Physician Assistant Conference(AAPA-IMPACT), Las Vegas, NV, May 30–June 4, 2011.

97E. Linagliptin effectively reduces HbA1c independent of age inpatients with type 2 diabetes. Marc Rendell, M.D.1, Steven Chrysant,M.D.2, Angela Emser, M.D.3, Max von Eynatten, M.D.3, Sanjay Patel,MB, ChB4, Angelina Trujillo, M.D.5, Hans-Juergen Woerle, M.D.3;(1)Creighton Diabetes Center, Omaha, NE; (2)OklahomaCardiovascular and Hypertension Center and University of OklahomaSchool of Medicine, Oklahoma City, OK; (3)Boehringer IngelheimPharma GmbH & Co. KG, Ingelheim, Germany; (4)BoehringerIngelheim Corporation, Bracknell, United Kingdom; (5)BoehringerIngelheim Pharmaceuticals, Inc., Ridgefield, CT PURPOSE: Previous studies have identified age as an underlyingcause for heterogeneity of treatment response with antidiabetic agents.We analyzed pooled data from >2,000 linagliptin-treated patients toevaluate whether age had any effect on safety and efficacy of thisDPP-4 inhibitor. METHODS: Identical endpoints, dosing, and large cohort size

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(N=2,258) in 3 randomized, double-blinded, placebo-controlledstudies facilitate subgroup analyses (post-hoc) by pooled dataset. The24-week primary efficacy outcome in all studies was mean changefrom baseline HbA1c. Any adverse events (AEs) were recorded. Age-based patient subgroups were: ≤50 (n=550), 51-64 (n=1134), 65-74(n=465), and ≥75 years (n=75). RESULTS: Mean baseline BMI was29.0±4.9 kg/m2. Patients were 58% White, 42% Asian, and 50.4%female. Overall, 57% had diabetes duration >5 years. Mean baselineHbA1c (±SD) was 8.1% (±0.8). Mean ages for subgroups were 44±5,58±4, 69±3, and 77±1 years. The pooled analysis of efficacy showedsignificant placebo-corrected HbA1c reductions with linagliptin in allsubgroups, with no age effect on efficacy (P=0.48) and no age-treatment interaction (P=0.65). Mean adjusted, placebo-correctedchanges from baseline HbA1c (±SE) were -0.58±0.08 (age ≤50), -0.68±0.06 (age 51–64), -0.60±0.09 (age 65–74), and -0.77±0.24 (age≥75). Overall AE incidence among linagliptin-treated patients wassimilar to or less than placebo across subgroups. Serious AE rateswere 2.5%, 3.1%, 4.3%, and 3.3% for linagliptin-treated patients,versus placebo: 3.7%, 2.6%, 4.8%, and 6.7%. Hypoglycemiaincidence was 8.3%, 11.8%, 12.1%, and 28.3% for linagliptinsubgroups, versus placebo: 4.3%, 7.2%, 12.9%, and 20%. However,hypoglycemia incidence was <1% in linagliptin monotherapy ormetformin (MET) add-on studies. Increased frequency (>1%) ofhypoglycemia only occurred in the study using MET+sulfonylurea asbackground. No linagliptin-related safety concerns were identified. CONCLUSION: Linagliptin safety/efficacy did not differ among agegroups. Linagliptin was effective for treating T2DM in all subgroups(including elderly), with safety profile comparable to placebo. Presented at Presented at the 93rd Annual Meeting of the EndocrineSociety, Boston, MA, June 4–7, 2011. Poster P3-497.

98. The effect of basal-bolus insulin vs. sliding scale insulin onquality indicators in hospitalized patients with type 2 diabetesmellitus on hemodialysis. Francine D. Salinitri, Pharm.D.1, NehaDesai, Pharm.D.2, Teuta Karanfili, Pharm.D., Candidate1, David W.Satterthwaite, Pharm.D. Candidate1, Opada Alzohaili, MD3, David A.Wilpula, Pharm.D., BCPS2; (1)Wayne State University, Detroit, MI;(2)Oakwood Hospital and Medical Center, Dearborn, MI; (3)SinaiGrace Hospital, Detroit, MI PURPOSE: Clinical trials evaluating the use of basal-bolus insulin(BBI) in hospitals often exclude patients with end-stage renal disease(ESRD). The aim of this study is to assess the effectiveness and safetyof BBI treatment in hospitalized patients with type 2 diabetes mellitus(DM) and ESRD. METHODS: This is a nonrandomized retrospective paired cohortstudy of hospitalized patients with type 2 DM and ESRD whoreceived separate courses of BBI and sliding scale insulin (SSI)treatments at distinct time periods between January 2008 and May2011. Patients were identified from coding reports of hemodialysisand insulin therapy. Patients received at least 3 days of insulin therapyin each treatment arm. The study excluded patients with age < 18years, type 1 DM, previous solid organ transplant, or concomitant useof other hypoglycemic agents. Demographics, point of care glucose,diet, and medication administration records were collected foranalysis. Outcome measures included quality indicators for glycemiccontrol recommended by the Society of Hospital Medicine. A 1-tailedpaired student’s t-test was used for all statistical measures. RESULTS: Seventeen patients were included in the analysis. BBItreatment improved unadjusted quality indicators of effectiveness:patient days with mean glucose < 140 mg/dL (10.9% vs 29.7%,p=0.024), patient days with mean glucose < 180 mg/dL (36.2% vs63.0%, p=0.006) and patient days with glucose measurements > 300mg/dL (22.0% vs 10.4%, p=0.046). Although not statisticallysignificant, patients experienced more hypoglycemia (4.5% vs 10.9%,p=0.184), including one episode of severe hypoglycemia, during BBItreatment. CONCLUSION: From a quality perspective, BBI significantlyimproved indicators of effectiveness and negatively impactedindicators of safety. BBI treatment may be a preferred therapeuticstrategy for hyperglycemia management in hospitalized patients onhemodialysis, however caution should be taken to minimize theincidence of hypoglycemia.

99. Association between vitamin D deficiency and diabeticretinopathy in the Third National Health and NutritionExamination Survey. Luigi Brunetti, Pharm.D.1, Saira Choudry,Pharm.D.1, Djibril S. Camara, M.D.2, Jianming He, M.A., MEdev,M.S.2; (1)Ernest Mario School of Pharmacy, Rutgers, The StateUniversity of New Jersey, Piscataway, NJ; (2)University of Medicineand Dentistry of New Jersey, Piscataway, NJ PURPOSE: This study was conducted to investigate if an associationexists between serum 25-Hydroxyvitamin D (25OHD) deficiency anddiabetic retinopathy (DR). METHODS: A total of 847 subjects with self-reported diabetesmellitus (DM), aged 40 years or older from the Third National Healthand Nutrition Examination Survey (NHANES III) were included inthe analysis. The exposure of interest was deficiency in serum 25OHD(defined as < 20 ng/mL) and the outcome of interest was a compositeof mild, moderate, or proliferative DR. Logistic regression was used toassess the association and account for potential confounders. Thefollowing covariates were included: age, gender, race, systolic bloodpressure (SBP), DM duration, and hemoglobin A1c (HbA1c) level. RESULTS: Subjects with acceptable serum 25OHD levels were 24%less likely to have DR; however, the reduction did not reachsignificance (OR=0.76; 95% CI: 0.49, 1.17). Likewise, after adjustingfor SBP and DM duration, the association remained (OR=0.71; 95%CI: 0.44, 1.14). HbA1c was found to be an effect modifier; therefore,the analysis was stratified by HbA1c (≤ 7% or > 7%). After adjustingfor SBP and DM duration, subjects with an HbA1c ≤ 7% withsufficient serum 25OHD were 64% less likely to have DR (OR=0.36;95% CI: 0.16,0.80). The association was not observed in subjects witha HbA1c > 7% (OR=1.15; 95% CI: 0.63, 2.20). CONCLUSION: Based on the results from this study, there may be aweak association between Vitamin D deficiency and DR for patientswith DM in the U.S. After adjusting for SBP and duration of DM,subjects at goal HbA1c, with sufficient serum 25OHD, were lesslikely to have DR. Since cross-sectional data do not provide temporalrelationships, further research is warranted in observing a relationshipbetween 25OHD deficiency and DR.

Gastroenterology

100. Are proton pump inhibitors associated with the developmentof community acquired pneumonia: a meta-analysis. ChristopherA. Giuliano, Pharm.D.1, Sheila M. Wilhelm, Pharm.D., BCPS2,Pramodini B. Kale-Pradhan, Pharm.D.1; (1)Wayne State University,Eugene Applebaum College of Pharmacy and Health Sciences and St.John Hospital and Medical Center, Detroit, MI; (2)Wayne StateUniversity, Eugene Applebaum College of Pharmacy and HealthSciences and Harper University Hospital, Detroit, MI PURPOSE: Proton Pump Inhibitors (PPIs) are routinely utilized inboth inpatient and outpatient settings. There are conflicting results thatindicate PPIs are associated with pneumonia. This analysis willevaluate the association of PPI and community acquired pneumonia(CAP). METHODS: This meta-analysis only included case controlled andcohort studies which were published in full in English and evaluatedPPI use and CAP incidence. Studies were excluded if they includedthe following patients: pediatric, H.pylori treatment, and critically ill.PubMed was searched using the terms PPI, pneumonia, omeprazole,esomeprazole, lansoprazole, pantoprazole, rabeprazole. Hand searchesof recent systematic reviews or other analyses or articles for additionalreferences were completed. Quality of studies was assessed using theNewcastle Ottawa Quality Assessment Scale (NOQAS). Twoinvestigators independently extracted data into standardized datacollection forms which was confirmed by a third investigator. Datawas analyzed based on current use of PPIs, duration of PPI use (<30days, >180days), PPI dose (high versus low), and use of any acidsuppressive therapy (Histamine2 Receptor Antagonist or PPI). Overallassociation of PPI and CAP was analyzed using the random effectsmodel (Comprehensive Meta analysis® Ver 2.0). RESULTS: Ten studies met all criteria. NOQAS scores ranged from4-8 out of 9. Current use of PPIs (OR 1.39, 1.09–1.76), PPI use <30days (OR 1.65, 1.25–2.19), PPI high dose (OR 1.50, 1.33–1.68) andPPI low dose (OR 1.17, 1.11–1.24) were significantly associated withCAP: There was no association between CAP and PPI use >180days


(OR 1.10, 1.00–1.21) or use of any acid suppressive therapy (OR 1.24,0.99–1.55). CONCLUSION: Patients currently receiving PPIs, particularly <30days or high dose, showed an association with CAP. Practitionersneed to be vigilant about adverse effects of PPIs and consideralternative therapies.

101E. A Multi-Center, Double-Blind, Parallel-Group Study toEvaluate Short-Term Safety and Efficacy and Long-termMaintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1 to 11 Year-Old PediatricSubjects with Endosco. Gerhard J. Leitz, M.D., Ph.D.1, IbrahimHaddad Sr., M.D.2, Steven Silber, M.D.3, Andrew Mulberg, M.D.1;(1)Johnson & Johnson Pharmaceutical Research & Development,L.L.C., Titusville; (2)Pediatric & Adolescent Gastroenterology &Nutrition, Youngstown, OH, United States, OH; (3)Johnson andJohnson PRD, Titusville, NJ PURPOSE: The primary objective of this study was to evaluate theefficacy and safety of two target dose level of a Rabeprazole SodiumDelayed-Release Pediatric Bead Formulation in pediatric subjects, 1 to11 years of age with endoscopically proven gastroesophageal refluxdisease (GERD). METHODS: All subjects had to have a grade 1 or higher on theHetzel and Dent and grade >0 on the Histological Reflux Esophagitisscales. Following screening, subjects were randomized in a multi-center, double-blind, parallel-group design to receive either 0.5 mg/kgor 1.0 mg/kg of Rabeprazole for 12 weeks. The primary endpoint wasendoscopic/histological healing defined as grade 0 on the Hetzel &Dent Scale or grade 0 on the Histological Reflux Esophagitis Scale. RESULTS: Thirty sites in the US, 38 sites in Europe and two sites inIndia randomized 127 subjects during 30-Jan-09 to16-May-2010. Theoverall healing rate after the 12-week treatment period was 81%: 78 %for 0.5 mg/kg and 83% for 1.0 mg/kg. Consistent with theendoscopic/histological healing rate, the frequency and severity ofGERD symptoms decreased substantially. There was no apparentpattern between the two treatment arms regarding treatment emergentadverse events (TEAEs) and serious adverse events. The frequency ofTEAEs was 74% for 0.5 mg/kg and 77% for 1.0 mg/kg. CONCLUSIONS: Both, the 0.5 mg/kg and 1.0 mg/kg dose regimenof the Rabeprazole Sodium Delayed-Release Pediatric BeadFormulation were effective and safe in pediatric subjects, 1 to 11 yearsof age. The clinical effect and the safety profile were similar for bothdose levels. No unexpected adverse events were reported in thispopulation of children with endoscopically proven GERD. Presented at Presented at DDW in Chicago, May 2011

Geriatrics

102. GFR equations overestimate creatinine clearance in elderlyindividuals enrolled in the NIA-Baltimore Longitudinal Study onAging (BLSA). Thomas C. Dowling, Pharm.D., Ph.D.1, John D.Sorkin, M.D., Ph.D.2, Luigi Ferrucci, M.D., Ph.D.3; (1)Department ofPharmacy Practice and Science, University of Maryland School ofPharmacy, Baltimore, MD; (2)Division of Gerontology, University ofMaryland School of Medicine, Baltimore, MD; (3)BiomedicalResearch Center, National Institute on Aging, Baltimore, MD PURPOSE: Equations developed to estimate glomerular filtration rate(eGFR) have not been adequately validated for use in elderlyindividuals with impaired kidney function. The purpose of this studywas to compare eGFR equations to creatinine clearance (CLcr) in acohort of elderly participants in the NIA-BLSA study. METHODS: A random cross-sectional sample of non-hospitalizedBLSA study participants aged > 70 years who had 24-hour measuredcreatinine clearance (mCLcr) values < 70 mL/min and BMI < 40kg/m2 were evaluated. Kidney function was estimated using theCockcroft-Gault (CG), Modification of Diet in Renal Disease Study(MDRD) and Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equations. The performance of eGFR equations wasassessed by measuring bias and precision relative to mCLcr and CG. RESULTS: The dataset included 269 participants aged 81±6 yearswith serum creatinine (Scr) of 1.2±0.3 mg/dL, body surface area of1.8±0.2 m2 and mCLcr of 53±13 mL/min. The CG equation (50±14mL/min) was the only equation to provide an unbiased estimate of

mCLcr. The MDRD and CKD-EPI were significantly positivelybiased compared to CG (+34±20% and +22±15%, respectively,p<0.001) and mCLcr (+29±47% and 18±40%, respectively, p<0.001).The CKD-EPI was more precise than MDRD but was 10±6% lowerthan MDRD (p<0.001). For subjects with Scr <1.0 mg/dL (n=103),rounding Scr up to 1.0 mg/dL resulted in CG values that weresignificantly lower than mCLcr (44 ±10 mL/min vs. 56±12 mL/min,respectively, p<0.001). CONCLUSION: The MDRD and CKD-EPI eGFR equationssignificantly overestimate creatinine clearance (mCLcr and CG) inelderly individuals. These eGFR equations should not be substitutedfor the CG equation in elderly for the purpose of renal doseadjustments. The common practice among pharmacists of roundingserum creatinine up to the arbitrary value of 1.0 mg/dL in elderly forapplication in the CG equation should be avoided.

103. Targeting testosterone concentrations in elderly males usingtransdermal testosterone gel. Joseph P. Vande Griend, Pharm.D.1,Tammie K. Nakamura, M.A.2, Daniel W. Barry, M.D.2, Pamela Wolfe,M.S.3, John M. Kittelson, Ph.D.3, Wendy M. Kohrt, Ph.D.2, Robert S.Schwartz, M.D.2; (1)University of Colorado, School of Pharmacy,Aurora, CO; (2)University of Colorado, School of Medicine, Aurora,CO; (3)Department of Biostatistics and Informatics, Colorado Schoolof Public Health, Aurora, CO PURPOSE: Guidelines recommend testosterone replacementtargeting total testosterone concentrations [TT] in the normal range(300–1000 ng/dL) for elderly males with androgen deficiency.However, safety and/or efficacy differences may exist throughout thiswide range. This study sought to evaluate the ability of a dose-titrationprotocol utilizing transdermal testosterone gel (Androgel®) to target“low-normal” (400–550 ng/dL) and “high-normal” (600–1000 ng/dL)[TT]. METHODS: This titration protocol was used in a one-year,randomized, double-blind, placebo-controlled, trial (NIHRO1AG019339), in healthy older men (>60 years) with baseline [TT]of 200–350 ng/dL. Titration dose was initiated at 2.5 gm in “low-normal” (n=47) and at 5 gm in “high-normal” (n=50) subjects.Another 53 subjects received placebo gel. Doses were titrated(up/down) in 1.25–2.5 gm increments in response to serial 2-week[TT], with the goal of 2 consecutive values within range during thefirst 12 weeks. However, titration continued for up to 6 months in 44%of active drug-treated subjects. RESULTS: At end of titration, “low-normal” and “high-normal”subjects were prescribed mean (SD) doses of 4.4 gm (1.2) and 7.3gm(1.5), respectively (p<0.0001). [TT] increased from 291 ng/dL (44.8)to 516 ng/dL (298; range: 131–1626 ng/dL) in “low-normal” subjectsand from 301.5 ng/dL (40.3) to 532.8 ng/dL (299; range: 171–1351ng/dL) in “high-normal” subjects (p=0.8 between groups). Placebosubjects had baseline [TT] of 292.3 ng/dL (39) and [TT] of 304 ng/dL(80.4) at titration end. Only 32% of “low-normal” subjects and 20% of“high-normal” subjects achieved target range at titration end.Adherence was not different among the 3 study groups (> 80%) andwas not different between those who did/not achieve target range. CONCLUSION: Despite a careful titration protocol, good adherence,and a 66% difference in prescribed dose, [TT] did not differsignificantly between the active treatment groups. Achievement oftarget range was suboptimal. The marked variability in individualresponse to Androgel® treatment may make it clinically difficult tosuccessfully target a specific [TT] range.

104. Assessing the appropriateness of proton pump inhibitorutilization in hospitalized elderly patients. Cheryl R. Durand,Pharm.D., Kristine C. Willett, Pharm.D., Alicia R. Desilets, Pharm.D.;Massachusetts College of Pharmacy and Health Sciences, Manchester,NH PURPOSE: The primary objective of this study is to assess theappropriate use of proton pump inhibitors (PPIs) in elderlyhospitalized patients and determine if continuation after discharge waswarranted. Recent early clinical studies suggest that PPIs mayincrease a person’s risk of developing pneumonia, hip fracture, andgastrointestinal infection. METHODS: This study was approved by the hospital’s InstitutionalReview Board. A retrospective chart review was conducted using the

339e


hospital’s electronic medical record. A random sample of patients 18and older who were ordered to receive an intravenous or oral PPIbetween March and April of 2010 were included. PPI therapy wasconsidered appropriate if one of the following indications wasdocumented in the patient’s medical record: gastric ulcer, erosiveesophagitis, gastroesophageal reflux disease, duodenal ulcer,Helicobacter pylori, risk reduction for NSAID-associated ulcer,Zollinger-Ellison syndrome, gastrointestinal bleed, or those meetingthe criteria for stress ulcer prophylaxis. Appropriateness of PPItherapy upon discharge was determined based on the PPI indicationand the duration of treatment recommended in the respectiveguidelines. Fisher’s exact test was used to determine statisticalsignificance. RESULTS: A total of 180 patients were included in the study, 99(55%) patients were age 65 and older and 81 patients were under age65. PPI therapy was considered inappropriate in 52 of those age 65and older as compared to 26 patients less than 65 (52.5% vs 32%respectively, p=0.0067). There was no statistically significance ofinappropriate continuation of a PPI upon discharge between the twogroups. CONCLUSION: Inappropriate use of PPIs may exist morecommonly in the hospitalized elderly population. Due to the potentialof PPIs to increase the risk of pneumonia, hip fracture and GIinfections, the risks of their use in some instances may outweigh thebenefits.

Health Services Research

105. Evaluation of Specialized Medication Packaging Combinedwith Medication Therapy Management: Adherence, Outcomes,and Costs among Medicaid Patients. Alan J. Zillich, Pharm.D.1,Margie E. Snyder, Pharm.D., M.P.H.1, Heather Jaynes, RN, M.S.1, JeffHarrison, Ph.D.2, Carl de Moor, Ph.D.3, Dustin D. French, Ph.D.4,Karen S. Hudmon, Dr.P.H., M.S.1; (1)Purdue University College ofPharmacy, Indianapolis, IN; (2)University of Auckland School ofPharmacy, Auckland, New Zealand; (3)REGISTRAT-MAPI,Lexington, KY; (4)Roudebush VA Medical Center, Health ServicesReseach and Development, Indianapolis, IN PURPOSE: This study evaluates the effect of a program usingspecialized medication packaging combined with telephonicmedication therapy management on medication adherence, healthcareutilization, and costs among Medicaid patients. METHODS: A retrospective cohort design compared Medicaidparticipants who voluntarily enrolled in the program (n=1,007)compared with those who did not (n=13,614). Main outcome measureswere medication adherence at 12 months, hospital admissions andemergency department (ED) visits at 6 and 12 months, and total paidclaim costs at 6 and 12 months. Appropriate regression models wereused to adjust for the effect of age, sex, race, co-morbidities, and 12-month pre-enrollment healthcare utilization and costs. RESULTS: Across 10 therapeutic classes, measures of medicationadherence were significantly improved in the intervention cohortcompared with the usual care cohort. At six months, adjusted all-causehospitalization was marginally less in the intervention cohortcompared with the usual care cohort (OR=0.73, CI:0.54–1.0, p=0.05).No statistically significant differences were observed between the twocohorts for any of the other adjusted utilization endpoints at 6 or 12months. Adjusted total cost at 6 and 12 months were higher in theintervention cohort (6-month Cost ratio=1.76, CI:1.65–1.89; 12 monthCost Ratio=1.84, CI:1.72–1.97), due primarily to an increase inprescription costs. ED visits and hospitalization costs did not differbetween groups. CONCLUSION: The program improved medication adherence, butthe effect on healthcare utilization and non-pharmacy costs at 6 and 12months was not different from the usual care group. Reasons for thesefindings may reflect differences in the delivery of the specializedpackaging and implementation of the MTM program, healthcarebehaviors in this Medicaid cohort, unadjusted confounding, and timerequired for the benefit of the intervention to manifest.

106. Impact of pharmacist-led antimicrobial stewardship using acomputerized system with prospective audit and feedbackapproach in a university hospital. Chu-Chun Chen, B.S.1, Tzu-

Hsuan Lu, B.S.1, Yung-Ching Liu, M.D.2, Shiu-Yu Chien, M.S.1,Ming-Der Chao, M.S.1, Wuan-Jin Leu, M.S.1; (1)Department ofPharmacy, Shuang Ho Hospital, Taipei Medical University, NewTaipei, Taiwan; (2)Division of Infection Diseases, Department ofInternal Medicine, Shuang Ho Hospital, Taipei Medical University,New Taipei, Taiwan PURPOSE: Antimicrobial stewardship program is proven to reduceimproper use, resistance and cost of antimicrobials in guidelines. Apharmacist-led program with computerized system support may bemore feasible to provide stewardship service in a limited resourcessetting. METHODS: In 2010, a dual antimicrobial stewardship program wasconducted at a 500- bed university hospital in Taipei, Taiwan. Thecomputerized antimicrobial system guided the use of 17 restrictedantimicrobials by criteria-based order sets. A clinical pharmacist whoworks in conjunction with infectious disease physician providedstewardship service by prospective audit and feedback approach.Parenteral antimicrobial utilization was analyzed using defined dailydoses (DDD) per 1000 patient-days (PDs). Financial impact expressedin the rate of antibiotics cost to total drug expenditure, and the absenceof National Health Insurance (NHI) reimbursement estimated in NTDollar, were also compared before and after program initiation. RESULTS: During one year period, the intensive antimicrobialcontrol program reduced the consumption of parenteral antimicrobialsfrom 1152.8 DDD per 1000 PDs in 2009 to 1121.5 DDD per 1000PDs in 2010. The absence of National Health Insurancereimbursement was declined from 13,730,127 NT Dollar in 2009 to12,582,250 NT Dollar in 2010. Also, the percentage of antibiotics tototal drug expenditure decreased significantly from 33% to 27%.Approximately eighty percent of stewardship recommendations wereaccepted using primarily a prospective audit and feedback approachby pharmacist. CONCLUSION: Our program demonstrated that the computerizedorder sets provide guidance to clinicians in antimicrobial utilization,and pharmacist can take a leadership role to positively improveappropriate use and cost saving of antimicrobials at the institutionallevel.

107. Associations between communication climate and thefrequency of medical error reporting among pharmacists withinan inpatient setting. Mark E. Patterson, Ph.D., M.P.H.1, Heather A.Pace, Pharm.D.2, Linda Garavalia, Ph.D.1, Jack E. Fincham, Ph.D.,R.Ph.1; (1)University of Missouri-Kansas City School of Pharmacy,Kansas City, MO; (2)UMKC School of Pharmacy Drug InformationCenter, Kansas City, MO PURPOSE: Open communication amongst pharmacists is animportant factor in ensuring the success of medical error reportingsystems. The likelihood of using these error reporting systems may becompromised within a work climate of poor communication,potentially resulting in the underreporting medical errors. Theobjective of this analysis is to identify the extent to which perceivedcommunication climate among hospital pharmacists impacts medicalerror reporting rates. METHODS: This cross-sectional study used survey responses from5000 pharmacists originating from the 2010 Hospital Survey onPatient Safety Culture Comparative Database. Perceivedcommunication climate was defined using scores from two surveydomains: 1) communication openness and 2) feedback andcommunication about error. Within these two domains, pharmacist-level composite scores were constructed by calculating median Likertscale scores. Error reporting frequency was defined using responsesfrom the survey question: ‘In the past 12 months, how many eventreports have you filled out and submitted?’ Multivariable logisticregressions were used to estimate the likelihood of medical errorreporting among pharmacists conditional upon perceivedcommunication openness or feedback levels, controlling forpharmacist years of experience, hospital geographic region andownership status. RESULTS: Poorer communication openness scores were associatedwith decreased likelihood of medical error reporting (OR=0.75, 95%CI 0.57–1.0, p=0.03), while communication feedback scores were notassociated with medical error reporting (OR=0.88, 95% CI 0.68–1.1,p=0.26).


CONCLUSION: Work climates not conducive to questioning clinicaldecisions that undermine patient care decreases the likelihood ofpharmacists reporting medical errors, while work settingsincorporating feedback based upon prior errors may not affect thelikelihood of error reporting. Further studies need to be conducted toexplore causal nature of these associations, most especially sincecommunication climate potentially impacts patient safety.

108. Alternative Methods for Disseminating Evidence-BasedPrescription Drug Information among Primary Care Clinicians inRural Oregon: The Rural Oregon Academic Detailing (ROAD)Project. Daniel M. Hartung, Pharm.D., M.P.H.1, Ann Hamer,Pharm.D.2, Dean Haxby, Pharm.D.2, Luke Middleton, B.S.3, Lyle J.Fagnan, M.D.4; (1)Oregon State Univ/Oregon Health & Science Univ.,College of Pharmacy, Portland, OR; (2)Oregon State University /Oregon Health & Science University, Portland, OR; (3)Oregon StateUniversity, Portland, OR; (4)Oregon Health & Science University,Portland, OR PURPOSE: Academic detailing is technique for delivering non-commercial education to clinicians in an interactive, convenient, anduser friendly approach. While a growing body of evidence suggestsacademic detailing is associated with a modest, but significant, impacton changing prescribing behavior, uncertainty exists about itsgeneralizability. The goal of our study was to evaluate differentapproaches to delivering academic detailing to primary care cliniciansin rural Oregon. METHODS: We conducted a pilot project to assess the feasibility,effectiveness, and satisfaction of academic detailing delivered in aface-to-face format compared to a distance detailing approach in fourrural primary care clinics within the Oregon Rural Practice-basedResearch Network. In order to assess needs, topic preferences, andinfrastructure for receiving distance education we conducted focusgroups and baseline surveys in each clinic prior to launch. Two clinicswere allocated to receive face-to-face detailing and two receivedoutreach through video conferencing or asynchronous web-basedoutreach. Surveys at midpoint and completion were used to assesseffectiveness and satisfaction. RESULTS: Each clinic received four outreach visits over a ninemonth period. Topics included treatment-resistant depression,management of atypical antipsychotics, drugs for insomnia, andbenzodiazepine tapering. For all responses, differences between theface-to-face and distance detailing groups did not reach statisticalsignificance. Overall, 90% of participating clinicians were satisfiedwith the program in general. Between 70–90% of respondentsindicated they would change their prescribing practices consistentwith our educational message. While 90–100% of respondentsindicated they would continue to participate if the program wascontinued, the likelihood of participation declined when only distanceapproaches were offered. CONCLUSIONS: We found strong support and satisfaction for ourpilot program of academic detailing in rural primary care clinics.Participants favored in-person approaches to distance interactions.Future efforts will be directed at quantitative methods for evaluatingthe effectiveness of this approach.

109. Combining a clinical pharmacy economic intervention toolwith an intervention documentation system. Adam B. Pesaturo,Pharm.D., Erin Taylor, Pharm.D., Caryn Colburn, B.S., AudreyBernard, Pharm.D., Mark Heelon, Pharm.D.; Baystate Medical Center,Springfield, MA PURPOSE: To improve documentation of clinical pharmacyservices/interventions and to associate those interventions with a costavoidance value. METHODS: The Department of Pharmacy partnered with theDepartment of Information Systems to create an interventiondocumentation tool within our existing electronic medical record(eMR) (Cerner Millennium, Cerner Corporation, Kansas City, MO).We tied this intervention tool with a clinical pharmacy economictracking tool purchased by the hospital’s finance department (ActionO-I, Thompson Reuters, New York, NY). Retrospective tracking wasperformed for the purpose of quality improvement. The interventionrate was monitored monthly and standardized to the number ofinterventions per 1000 patient days. Prior documentation used an

external database and the intervention rate from this period served asthe comparator. The cost avoidance value was tracked monthly andconverted into a return on investment (ROI) value. RESULTS: A clinical pharmacy intervention tool was created thatcould be accessed from multiple locations within the eMR. Theaverage monthly interventions per 1000 patient days increased afterincorporation into the eMR (37±7 vs. 90±34, p=0.5). Pre-definedinterventions were assigned a value based on availablepharmacoeconomic studies, institution-specific acquisition costs, andaverage length of treatment. Monthly reporting allowed a costavoidance dashboard to be maintained and a clinical pharmacy ROI.To date, the department of pharmacy has avoided $271,162 over twomonths and has an associated ROI of $0.54 for every $1.00 spent. CONCLUSION: Through collaboration with the departments ofInformation Systems and Finance, the Department of Pharmacy wasable to create a clinical pharmacy economic interventiondocumentation tool that is evidence-based, institution-specific,accepted by finance officials, incorporated into an existing patient caresystem, comprehensive, and widely applicable to different clinicalsettings. Future steps involve additional staff training to ensureaccurate documentation and designing services that match thoseidentified within the economic tracking tool.

Hematology/Anticoagulation

110. Implementation of a standardized computerized physicianorder entry set for warfarin reversal improves evidenced-basedadministration of vitamin K. Jane D. Portell, Pharm.D.1, Craig A.McCammon, Pharm.D.1, Jennifer N. Riney, Pharm.D.1, Sebastian E.Perez, Pharm.D.1, Aaron Pierce, Pharm.D.2, Amber M. Sawyer,Pharm.D.3, Eli N. Deal, Pharm.D.1; (1)Barnes-Jewish Hospital, St.Louis, MO; (2)BryanLGH Medical Center, Lincoln, NE; (3)Universityof Missouri Hospitals & Clinics, Columbia, MO PURPOSE: Evaluate provision of vitamin K for warfarin reversalaccording to evidence-based guidelines following the implementationof a standardized order set incorporated into our institution’scomputerized physician order entry (CPOE) process. METHODS: This study was conducted as an observational, before-after study at a large, academic medical center. Practices for theadministration of vitamin K for warfarin reversal were compared in apre-intervention group (April 2009) and a post-intervention group(April 2011) following implementation of a CPOE order set. Patientsin each the pre- and post-intervention groups were compared based onappropriateness of vitamin K administration according to the 2008American College of Chest Physicians Guidelines. RESULTS: Doses of vitamin K in the pre-intervention group wereappropriate in 18/105 (17.1%) cases, while 34/94 (36.2%) cases in thepost-intervention group were appropriate (p<0.001). Patients thatreceived vitamin K from the CPOE standardized order set had thehighest proportion of correct vitamin K use (27/47, 57.4%). Vitamin Kadministration for patients experiencing a significant bleed improvedin the post-intervention phase (7/40, 17.5% pre-intervention vs. 13/39,33% post intervention, p=0.04). In the post-intervention phase, themost common reasons for incorrect vitamin K administration were asfollows: no therapy needed (n=8), given by non-preferred route(n=39), incorrect dose (n=33), and incorrect duration of therapy (n=4).Use of non-preferred routes of vitamin K was reduced in the post-intervention phase (subcutaneous 17/105, 16.2% vs. 11/94, 11.7% andintramuscular 2/105, 1.9% vs. 0/94, 0%). CONCLUSION: Administration of vitamin K for warfarin reversalaccording to evidenced-based guidelines was improved following theimplementation of a standardized order set incorporated into CPOE ata large, academic medical center.

111. Obesity affects time to INR≥1.5 in surgical orthopedicpatients initiated on warfarin for venous thromboembolismprophylaxis. Nicole E. Cieri, Pharm.D., Cynthia Lackie, Pharm.D.,Kristen Kusmierski, Pharm.D.; Millard Fillmore Suburban Hospital,Williamsville, NY PURPOSE: Anticoagulation Management Service (AMS)pharmacists at Millard Fillmore Suburban Hospital initiate warfarindosing based on a Pharmacy and Therapeutics Committee approvedage-adjusted guideline. The objectives of this review are to determine

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whether obese patients take longer to achieve an early INR target of≥1.5 and if necessary, to propose revision to improve dosing in thesepatients. METHODS: Data was collected via retrospective review. All surgicalorthopedic patients initiated on warfarin for venous thromboembolism(VTE) prophylaxis, from September 1, 2009 to April 30, 2010, withINR maintenance range of 2–3 and dosed by the AMS for ≥ 3 dayswere included. Patients ≤18 years old, those with physician directeddosing, receiving epidural anesthesia, receiving vitamin K within thepreceding two weeks or warfarin within one week were excluded.Data collected and analyzed included patient demographics, INR data,warfarin dose data, outpatient bleeding risk index criteria, and factorsaffecting warfarin sensitivity. RESULTS: Obese surgical orthopedic patients (BMI ≥ 30) failed toreach an early target INR for VTE prophylaxis (p<0.05).Classification and regression tree analysis revealed thresholds forlikelihood of achieving targeted INR as TBW 80.9 kg, BMI 29.8kg/m2 and age 76.5 years. All three thresholds were statisticallysignificant via chi square analysis (p<0.01) as well as univariateanalysis (p<0.05). Arbitrary thresholds (TBW=80kg and BMI=30kg/m2) were also statistically significant using chi square analysis. CONCLUSION: Obesity (based on either TBW or BMI) had aneffect on time to an early target INR in surgical orthopedic patientsinitiated on warfarin for VTE prophylaxis. A higher dose pathway orseparate protocol taking into account weight as well as age-adjustments (similar to the current protocol) may be necessary forobese patients to reach early target INR. The arbitrary values(TBW=80kg and BMI=30kg/m2) may be more practical forimplementation. Further investigations are recommended for increasedstarting doses of warfarin.

112. Majority of patients treated with warfarin for atrialfibrillation are willing to switch to dabigatran. Hazem F. Elewa,R.Ph., Ph.D., BCPS, Christina Deremer, Pharm.D., BCPS, KimbleKeller, Pharm.D., BCPS, Jaspal Gujral, MBBS, MRCP(UK), FACP ;Georgia Health Sciences University, Augusta, GA Background: Warfarin is an anti-coagulant medication that ischallenging to manage due to its multiple drug and food interactions,frequent laboratory monitoring and individually-based dosing.Therefore, it is often not maintained appropriately and its rate ofdiscontinuation is high. Recently, dabigatran has been approved by theFDA for non-valvular atrial fibrillation as an alternative to warfarin.Dabigatran does not require routine monitoring, has an establisheddose and lacks many of the drug, herbal and food interactions thatafflict warfarin. PURPOSE: to evaluate patients’ satisfaction with their currentwarfarin treatment through a brief survey in our pharmacy-based anti-coagulation clinic. In addition, patients with non-valvular atrialfibrillation were invited to express their opinion on switching to anewly marketed medication (dabigatran). METHODS: survey questions were on the scale from 1-5, 1 being theleast and 5 being the highest. RESULTS: Our preliminary data included 110 out of 280 plannedsurveys. Patients expressed high satisfaction with warfarin treatment(median=5) (Answer “1” (1.8%); “2” (0.9%); “3” (3.6%); “4”(14.5%); “5” (75.5%) and 3.6% were missing). However, a vastmajority of the patients were willing to switch to an agent that:requires less frequent follow-up visits (median=5) (Answer “1” (8%);“2” (8%); “3” (8%); “4” (22%); “5” (48%) and 6% were missing);lacks interaction with food or beverage (median=5) (Answer “1”(8%); “2” (2%); “3” (16%); “4” (10%); “5” (56%) and 8% weremissing); is as efficacious as warfarin (median=4) (Answer “1” (12%);“2” (8%); “3” (16%); “4” (14%); “5” (42%) and 8% were missing).Patients expressed that out-of-pocket cost of >$50 would be a majorbarrier to switch to this new medication (<$10 (64%), $10-$50 (18%),$50-100 (2%), $100-300(2%) and 14% were missing). CONCLUSION: patients are willing to consider a more convenientnew anti-coagulant treatment but cost remains a significant barrier.

113. Chronic Kidney Disease and Anticoagulation Instability inWarfarin-Treated Patients: Insights into Potential TreatmentStrategies. Candice L. Garwood, Pharm.D.1, Jennifer L. Johnson,Pharm., D.2, Shannon Habermas, Pharm.D., Student1, Peter Whittaker,

PhD3; (1)Wayne State University, Detroit, MI; (2)Wayne StateUniversity Eugene Applebaum College of Pharmacy and HealthSciences, Detroit, MI; (3)Wayne State University School of Medicine,Cardiovascular Research Institute and Dept of Emergency Medicine,Detroit, MI PURPOSE: Chronic kidney disease (CKD) is associated withanticoagulation instability in warfarin-treated patients. However, thecharacteristics of such instability and specific treatment approachesremain known. Therefore, we aimed to; (1) gain insight into CKD-associated instability by characterization of responses to interventionsdesigned to correct out-of-range international normalized ratio (INR),and (2) investigate a potential method of mitigating instability. METHODS: We examined records of patients (INR target 2.0–3.0)attending a pharmacist-managed clinic. To identify CKD-relatedinstability characteristics, we collected data on response to bothabove-range (3.2–3.4) and below-range INRs (1.6–1.8), all precededby in-range INRs. CKD patients had eGFRs <60 mL/min/1.73m2;controls >60 mL/min/1.73m2. The mitigation analysis comparedanticoagulation instability in CKD patients with different diets; thosewho ate 1–3 weekly green leafy vegetables (GLV) servings (a proxyfor vitamin K consumption), versus those who avoided GLVs. Ouranticoagulation instability measure was INR standard deviation (INR-SD); the larger the INR-SD, the greater the instability. We comparedCKD patients’ INR-SD in the two GLV groups. RESULTS: Patients (CKD=28; control=63) were predominantlyfemale African Americans. CKD patients were older (66±10.8 vs.60±10.7 years; P<0.02), but exhibited no other differences. Afterabove-range INRs (279 cases), controls returned to target range attheir next clinic visit 60% of the time versus 39% for CKD patients(P=0.0079). Importantly, there were no inter-group differences intreatment (dose adjustment or no intervention). After below-rangeINRs (244 cases), controls returned to target range 62% of the timeversus 63% for CKD patients (P=1.00): no treatment differences.CKD patients who avoided GLVs had lower INR-SD (0.63±0.05) thanthose who ate GLVs (0.82±0.07; P=0.043), consistent with increasedstability. CONCLUSION: CKD-associated instability was mitigated byavoidance of vitamin K-containing food. Furthermore, differentialresponses to out-of-range INRs indicate that CKD patients cannot betreated using the same strategies applied to other patients.

114. Timing of venous thromboembolism following total knee orhip replacement. Beth L. Nordstrom, Ph.D., M.P.H.1, Kathy Fraeman,SM2, Edith A. Nutescu, Pharm.D.3, Jeff Schein, Dr.P.H., M.P.H.4,Brahim Bookhart, M.B.A., M.P.H.4; (1)United Biosource Corporation,Lexington, M.A.; (2)United BioSource Corp, Lexington, MA;(3)University of Illinois at Chicago College of Pharmacy, Chicago, IL;(4)Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ PURPOSE: To investigate the occurrence of in-hospital vs post-discharge venous thromboembolism (VTE) following total hip or totalknee replacement (THR/TKR). METHODS: A retrospective cohort analysis was conducted using anelectronic medical record database. Data were obtained for patientsundergoing THR or TKR between January 1, 2004 and January 31,2009, who started warfarin within 3 days after surgery and had ?2 INRmeasurements. Individuals with a history of a previous VTE eventwere excluded from analysis. Patients were followed through theircontinuous warfarin therapy for up to 90 days to identify the presenceof VTE. Diagnosis codes for VTE events were classified as occurringduring the orthopedic surgery hospitalization or after discharge; thepost-discharge events were further characterized by the number ofdays since index (warfarin start). [0][0] RESULTS: A total of 1375 THR and 1667 TKR patients wereincluded in the VTE analysis. VTE occurred in 41 THR patients(3.0%) and 56 TKR patients (4.1%). The majority of these eventsoccurred during the hospitalization period; however, 34% of the THR-related events and 52% of the TKR-related events occurred during thepost-discharge period, with the highest risk of post-discharge eventsoccurring within the first 14 days after warfarin start. CONCLUSIONS: In this analysis, although the majority of VTEevents among orthopedic surgery patients occurred in-hospitalfollowing surgery, a third to one-half of VTE events were observedpost-discharge in THR and TKR patients, respectively. These findings


underscore the need for improved prophylaxis for VTE in THR andTKR patients, in both the in-hospital and post-discharge periods.Improved strategies and treatments post-discharge for VTEprophylaxis may also be warranted.

115. Outcomes associated with enoxaparin use among patientswith varying renal function. Megan A. Clairmont, Pharm.D.1,Douglas D. DeCarolis, Pharm.D., BCPS2, Joey Thorson, Pharm.D.2,Amy Leuthner, Pharm.D.2; (1)Minneapolis Veteran Affairs HealthCare System, Minneapolis, MN; (2)Minneapolis Veterans AffairMedical Center, Minneapolis, MN PURPOSE: Enoxaparin is a low-molecular-weight heparin that hasindications for use in many thromboembolic-related conditions.Enoxaparin is renally cleared and therefore package insert dosing callsfor a 50% dose reduction when creatinine clearance (CrCl) is <30ml/min. Despite linear pharmacokinetics, the full dose isrecommended for all patients with CrCl > 30ml/min, which includespatients with moderate renal impairment (CrCl 30–60ml/min).Although there is data showing drug accumulation in these patients,there is limited outcome data. METHODS: All patients who received therapeutic enoxaparintreatment courses between June 1, 2009 and November 30, 2009 wereidentified. Electronic medical records were retrospectively reviewedto identify baseline demographic, clinical, and bleeding riskinformation as well as outcomes of enoxaparin therapy. The primaryoutcome was major bleeding defined as a bleed resulting inhospitalization, emergency department visit or other unplannedambulatory care visit. We compared the incidence of this outcome inpatients with an estimated CrCl of ≥ 80ml/min versus those with aCrCl of 30–50ml/min. All patients received package insertrecommended doses. RESULTS: 170 patients with CrCl 30–50ml/min or ≥ 80 ml/min wereincluded in the study. The primary outcome occurred in 23.3% ofpatients with CrCl 30–50ml/min group and 7.3% of patients in CrCl ≥80ml/min group (p=0.003). No thromboembolic events were found ineither group. Baseline characteristics were not significantly differentbetween each renal function group. CONCLUSIONS: Patients with CrCl of 30–50ml/min hadsignificantly more hospitalizations, emergency room visits andunplanned primary care provider visits than patients with creatinineclearance ≥ 80ml/min. Patients with moderately impaired renalfunction need empiric enoxaparin dose adjustments or additionalmonitoring to avoid bleeding events and improve patient outcomes.

116. Bleeding rates among patients with morbid obesity treatedwith enoxaparin. Jennifer C. Hagopian, Pharm.D., Jennifer N. Riney,Pharm.D., James M. Hollands, Pharm.D., Eli N. Deal, Pharm.D.;Barnes-Jewish Hospital, St. Louis, MO PURPOSE: Using actual body weight to dose enoxaparin may lead toover-anticoagulation and increased bleeding risk, as low molecularweight heparins (LMWHs) distribute into the intravascularcompartment and not into tissues and body fat. The objective of thisstudy is to determine if there is an increased bleeding risk in morbidlyobese (body mass index [BMI] ≥40kg/m2) patients on treatment dosesof enoxaparin. METHODS: Patients were included if they were on treatment dosesof enoxaparin for at least 24 hours during the second half of 2009.Patients classified as morbidly obese comprised the study group andwere matched to controls (BMI<40 kg/m2) on a 1:2 ratio based uponrenal dysfunction (serum creatinine >1.4mg/dL). The final analysisincluded 100 morbidly obese patients and 200 control patients. Theprimary endpoint was the development of bleeding events up to 24hours after discontinuation of enoxaparin. RESULTS: Initial (0.96 mg/kg versus 1.05 mg/kg, p<0.01) and final(0.98 mg/kg versus 1.04 mg/kg, p<0.01) enoxaparin doses in morbidlyobese patients were significantly lower compared to control patients.The largest single dose given in either arm was 150 mg. The totalnumber of bleeding events did not differ between the treatment armsat 29 (29%) and 47 (23.5%) events between cases and controls,respectively, p=0.30. Increased number of doses (adjusted odds ratio[AOR] 1.07, 95% confidence interval [CI] 1.02–1.20), female gender(AOR 2.79, 95% CI 1.46–5.30), and increased peak serum creatinine(AOR 2.55, 95% CI 1.19–5.49) were found to be independent

predictors of bleeding. Avoidance of warfarin (AOR 0.51, 95% CI0.26–0.98) and lower final enoxaparin dose (AOR 0.08, 95% CI0.01–0.69) were protective against bleeding. CONCLUSION: Morbid obesity was not associated with increasedbleeding risk with therapeutic enoxaparin use. Results suggest thatdosing using actual body weight is appropriate and in accordance withcurrent CHEST guidelines.

117. Retrospective analysis of unfractionated heparin infusions inobese patients. Ann N. Biesboer, Pharm.D.1, William J. Peppard,Pharm.D.1, Garret L. Newkirk, Pharm.D.1, David J. Hermann,Pharm.D.1, Bethanne M. Held, Pharm.D.1, James G. Gosset, M.D.2;(1)Froedtert Hospital, Milwaukee, WI; (2)Medical College ofWisconsin, Milwaukee, WI PURPOSE: This study was designed to evaluate an institution’scurrent ≥40 kg/m2) patients compared to non-obese patients (BMI <30kg/m2) and to define an appropriate dosing strategy for all patientpopulations with respect to BMI and presence of thrombosis. METHODS: Electronic medical records were retrospectivelyreviewed to identify 373 inpatients who received a RESULTS: An association between BMI and UFH dose required toachieve two consecutive therapeutic partial ≥40 kg/m2 and 46 (38%)patients with BMI 30–39.9 kg/m2 were considered CONCLUSIONS: A strong association between BMI and UFH doseto achieve two consecutive therapeutic

118. Determining optimal vitamin K dosing to reverseanticoagulation based on baseline INR, route of administration,and home warfarin dose. Laura V. Tsu, Pharm.D., Erin Dienes, M.S.,William Dager, Pharm.D.; University of California, Davis MedicalCenter, Sacramento, CA PURPOSE: The objective of this study is to evaluate the impact ofbaseline INR, dose and route of vitamin K, and home warfarin dose onthe reduction of the International Normalized Ratio (INR) by vitaminK. METHODS: Medical records of 400 patients receiving vitamin K forwarfarin reversal between February 2008 and November 2010 werereviewed. Patient demographics, home warfarin dose, INR at baselineand for 48 hours after vitamin K administration was collected. RESULTS: The dose of vitamin K (p<0.001), route of administration(p<0.001), and baseline INR (p<0.001) significantly affected the INR.Compared to PO, IV vitamin K achieved more rapid and overallreductions in INR. Lower doses of IV vitamin K (0.5–1.25 mg)achieved a partial reversal in INR (1.5-2.0) at 48 hours, whereashigher doses (>1.25 mg) resulted in complete reversal (<1.5).Compared to patients with lower baseline INR, higher baseline INRreadings had higher INR readings at 24–48 hours. While the effect ofhome warfarin dose was not significant with both IV (p=0.269) andPO (p=0.981) vitamin K, it appeared that INR response to IV vitaminK is similar irrespective of home warfarin dose. With PO vitamin K,higher home warfarin doses (>2 mg/day) seemed to require largerdoses of vitamin K to achieve the same INR reduction compared topatients with lower home warfarin doses (≤2 mg/day). CONCLUSION: Depending on the desired level and timing of INRreduction, baseline INR as well as the route and dose of vitamin Kshould be taken into consideration when developing a vitamin K doseto expedite reversal of warfarin.

Herbal/Complementary Medicine

119. Effect of CoEnzyme Q10 supplementation on HMG-CoAreductase inhibitor-induced myalgias. Davd A. Bookstaver,Pharm.D., Nancy A. Burkhalter, Pharm.D.; Eisenhower Army MedicalCenter, Fort Gordon, GA PURPOSE: The purpose of the study was to assess the effect ofCoenzyme Q10 (CoQ10) supplementation on myalgias presumed tobe caused by HMG-CoA reductase inhibitor (statin) therapy. METHODS: Patients currently receiving a statin who developednew-onset myalgias in at least 2 extremities within 60 days ofinitiation or a dosage increase were eligible. Exclusions included adiagnosis of fibromyalgia or a serum creatine kinase level greater than300 units/liter. Patients continued statin therapy and were randomizedvia a matched-design to either CoQ10 60 mg twice daily or a

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matching placebo. Double-blind treatment continued for 3 months,and patients completed a 10 cm visual analog scale (VAS) and theShort-Form McGill Pain Questionnaire at baseline and at eachmonthly visit. The primary endpoint was the change from baseline at 1month in the VAS, and the difference between groups was evaluatedvia the Student’s t-test.RESULTS: Seventy-six patients were enrolled (40 CoQ10, 36placebo). The mean VAS was 6cm at baseline in both groups. At 1month, there was no difference in the mean VAS between the groups,3.9 cm CoQ10 and 4 cm placebo (p=0.97). Five patients in the CoQ10group and 3 in the placebo group discontinued therapy during the firstmonth due to myalgias. Both groups had a decrease to approximately3.1 cm on the VAS at the 3-month visit. The median score on theSensory Pain Rating Index subscale was 10 at baseline in the CoQ10group and 11.5 in the placebo group. At 1 month, these scoresdecreased to 6.5 and 7.5, respectively, which were not statisticallydifferent (p=0.34). CONCLUSION: CoQ10 supplementation was not effective in thetreatment of presumed statin-induced myalgias.

HIV/AIDS

120. Comparison of clinical outcomes between ritonavir-boostedatazanavir and unboosted atazanavir in HIV patients on aregimen containing tenofovir. James D. Scott, Pharm.D., M.Ed.,FCCP1, Kevin T. Marx, Pharm.D.2, Robert K. Bolan, M.D.2;(1)Western University of Health Sciences, Pomona, CA; (2)JeffreyGoodman Clinic, Los Angeles, CA PURPOSE: A significant drug-drug interaction occurs betweentenofovir (TDF) and atazanavir (ATV), which results in decreasedATV levels. As such, ATV should be boosted with ritonavir (RTV) inpts on a TDF-containing regimen. However, many patients areintolerant of RTV. As a result, some clinicians have used a non-approved combination of unboosted ATV with TDF to increaseadherence. Anecdotal reports suggest that this dosing of ATV withTDF usually results in undetectable viral loads (VL). We previouslyreported that subjects with unboosted ATV had better adherence thanthose with RTV boosted ATV (ATV/r). We now report on clinicaloutcomes associated with ATV vs. AVT/r when given with TDF. METHODS: This retrospective cohort study compared 49 subjects onregimens containing TDF and ATV (400 mg: n=32; 600 mg: n=17) to50 case-matched subjects on regimens containing TDF and ATV/r(300/100). Subjects were excluded based on age <18 yo, recentchanges to their ART, and creatinine clearance (CrCl) < 50 mL/min.Effectiveness was compared using changes in VL and CD4. Bilirubin,serum creatinine, and diagnoses of diarrhea while on the regimens arealso compared. RESULTS: ATV/r trended to be better at decreasing VL compared toATV (p=0.077), and attaining an undetectable VL was better in theATV/r group compared to ATV (84% vs. 61%, p<0.05), but were notdifferent between doses of ATV. Bilirubin increased more in the ATV/rsubjects than ATV subjects (2.7 ± 2.5 vs. 1.2 ± 1.4, p<0.0005). CD4count increases (ATV: 153 ± 154 cells vs. ATV/r: 213 ± 224) and CrCldecreases (9.9 ± 14.1 ml/min vs. 13.1 ± 18.2) were not different acrossgroups. Reports of diarrhea were uncommon. CONCLUSION: Despite better adherence with ATV compared toATV/r, viral load response was weaker. At this time, we cannotrecommend the use of ATV in combination with TDF unless the ATVis boosted.

121E. Hepatic Safety Profile of Fosamprenavir-ContainingRegimens in HIV-1-infected Patients with or without Hepatitis Cor B Co-infection. Belinda F. Ha, Ph.D.1, Brian C. Wine, M.S.1,Michael E. Wisniewski, Ph.D.1, Felipe Rodríguez-Alcántara, M.D.2,Mark S. Shaefer, Pharm.D.3; (1)GlaxoSmithKline, Research TrianglePark, NC; (2)ViiV Healthcare, Madrid, Spain; (3)ViiV Healthcare,Research Triangle Park, NC PURPOSE: We compared the hepatic safety profile of fosamprenavir(FPV) in antiretroviral-naïve and experienced HIV-1-infected patientswith or without hepatitis C (HCV, defined as anti-HCV positive) orhepatitis B (HBV, defined as HepB sAg positive) who had participatedin 7 clinical trials. METHODS: The following data were examined from 1319 HIV-

infected adults treated with FPV in combination with eitherabacavir/lamivudine or tenofovir/emtricitabine: incidence of Grade 2-4 adverse events (AEs), serious AEs, Grade 3/4 liver enzymeelevations (LEE), and change from baseline in alanineaminotransferase (ALT), aspartate aminotransferase (AST), and ASTplatelet ratio index (APRI) score over 48 weeks. RESULTS: In 205 co-infected patients (76% HCV, 28% HBV) and1,114 HIV-mono-infected patients, FPV regimens at baseline includedritonavir 100 mg (60%) or 200 mg (40%); 73% of the patients wereantiretroviral-naïve. Over 48 weeks, 38% (77/205) of co-infectedpatients reported Grade 2-4 drug-related AEs compared with 29%(320/1,114) of HIV-mono-infected subjects, and a similar proportionhad treatment-related serious AEs (8% [16/205] and 6% [62/1,114]).At Week 48, change from baseline in median ALT (range) in the co-infected and HIV-mono-infected groups was -4 (-142–344; n=100)and -7 (-183–141; n=716), in median AST was -6 (-116–266; n=96)and -6 (-179–78; n=715), and in median APRI score was -0.12 (-4.58–3.04; n=87) and -0.08 (-2.61–1.26; n=638). With respect totreatment-emergent LEE observed in 202 co-infected patients and1099 HIV-mono-infected patients over 48 weeks, the frequency ofGrade 3/4 ALT was 29 (14%) vs 12 (1%) and of Grade 3/4 AST was25 (12%) vs 16 (1%). CONCLUSION: Over 48 weeks, the co-infected and HIV-mono-infected groups had comparable liver enzyme decreases and incidenceof serious AEs, but the co-infected group had more Grade 2–4 drug-related AEs and treatment-emergent LEE. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.

122E. Efficacy and Safety of Abacavir/Lamivudine PlusRaltegravir at Week 96 in Antiretroviral-Naive HIV-1-InfectedPatients in the SHIELD Study. Benjamin Young, M.D., Ph.D.1,Thanes J. Vanig, M.D.2, Edwin DeJesus, M.D.3, Trevor N. Hawkins,M.D.4, Marty St.Clair, B.S.5, Britt S. Stancil, B.S.5, Belinda F. Ha,Ph.D.5; (1)Division of General Internal Medicine, University ofColorado, Denver, CO; (2)Spectrum Medical Group, Phoenix, AZ;(3)Orlando Immunology Center, Orlando, FL; (4)Southwest CareClinic, Santa Fe, NM; (5)GlaxoSmithKline, Research Triangle Park,NC PURPOSE: In the SHIELD study, a favorable efficacy and safetyprofile was previously reported with abacavir/lamivudine + raltegravirin treatment-naïve HIV-infected patients through 48 weeks. We nowreport long-term efficacy and safety findings. METHODS: This 96-week, open-label, pilot multicenter studyevaluated abacavir/lamivudine 600 mg/300 mg once daily + raltegravir400 mg twice daily in patients with entry viral load (VL) >1,000 c/mL.Patients were excluded if they were HLA-B*5701-positive or hadraltegravir, abacavir, or lamivudine resistance mutations. RESULTS: SHIELD enrolled 35 patients. At baseline, median VLwas 4.8 log10 c/mL, and median CD4+ 301 cells/mm3. Seven patients(20%) discontinued study, five between Weeks 48-96 after 471-788days of treatment (2 lost-to-follow-up [single site], 2 for non-compliance, 1 for lack of efficacy). At Week 48, 91% (32/35) had VL<50 c/mL (ITT:missing/discontinuation=failure analysis). At Week 96,the proportion of patients with VL <400 and <50c/mL was 80%(28/35) and 77% (27/35), respectively (ITT:missing/discontinuation=failure analysis); 74% (17/23) vs. 83% (10/12) hadVL <50 c/mL in the low (<100,000c/mL) vs. high (≥100,000c/mL)baseline VL strata, respectively. Median CD4+ change from baselinewas 304 cells/mm3. Six patients (17%) reported drug-related grade2–4 adverse events, 1 post-Week 48. Nine patients (26%) reportedgrade 3-4 lab abnormalities, 1 post-Week 48. No drug-related seriousadverse events were reported. Week 96 fasting lipid changes [median(95% confidence intervals) mg/dL] were not different from baselinefor total/HDL-cholesterol [-0.11 (-0.39, 0.46)] but increased fortriglycerides [25 (1.5, 64.5)], LDL-cholesterol [11 (7.5, 21.5)], HDL-cholesterol [6 (4–11.5)], and total-cholesterol [28 (20–40)]. CONCLUSION: In this pilot study, abacavir/lamivudine + raltegravirprovided continued/durable virologic suppression through Week 96 inpatients who remained on treatment. The combination was generallywell tolerated with few additional toxicities reported after Week 48. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.


123E. Efficacy/Tolerability of Unboosted Atazanavir VersusAtazanavir/Ritonavir, Each in Combination withAbacavir/Lamivudine, after Initial Suppression withAbacavir/Lamivudine+Atazanavir/Ritonavir in HIV-1-infectedPatients: 144-Week Results of ARIES. Kathleen E. Squires, M.D.1,Benjamin Young, M.D., Ph.D.2, Edwin DeJesus, M.D.3, Nicholaos C.Bellos, M.D.4, Daniel Murphy, M.D.5, Henry Zhao, Ph.D.6, Lisa L.Ross, M.S.6, Mark S. Shaefer, Pharm.D.7; (1)Thomas JeffersonUniversity, Philadelphia, PA; (2)Division of General InternalMedicine, University of Colorado, Denver, CO; (3)OrlandoImmunology Center, Orlando, FL; (4)Southwest Infectious DiseaseAssociates, Dallas, TX; (5)Clinique Medicale L’Actuel, Montreal, QC,Canada; (6)GlaxoSmithKline, Research Triangle Park, NC; (7)ViiVHealthcare, Research Triangle Park, NC PURPOSE: Induction with a ritonavir-boosted protease inhibitorregimen followed by simplification (ritonavir deletion) may offersustained virologic suppression while minimizing potential long-termadverse effects. METHODS: In ARIES, North American antiretroviral-naïve patientsinitiated on abacavir/lamivudine+atazanavir/ritonavir with confirmedHIV-RNA 50 c/mL and no protocol-defined virologic failure(confirmed rebound of HIV-RNA ≥400 c/mL) at Week 36 wererandomized 1:1 to maintain or discontinue ritonavir for 48 subsequentweeks. At Week 84, patients could continue their randomized regimeninto an extension phase through 144 weeks. RESULTS: Of 379 enrolled patients, 369 entered the extension phase,and 314 (85%) completed 144 weeks. Baseline demographics of the369 extension-phase patients were similar between arms and to theWeek 36 randomized population (mean age 39 years; 85% male; 64%white; HIV-RNA 5.06 log10 copies/mL; median CD4+ 198 cells/mm3).At 144 weeks, intent-to-treat-exposed analysis showed that theabacavir/lamivudine+atazanavir (n=189) and abacavir/lamivudine/lamivudine+atazanavir/ritonavir (n=180) groups responded similarlywith respect to proportion achieving HIV-RNA <50 c/mL (146[77%])vs 132[73%], p=0.390) and <400 c/mL (159[84%] vs 144[80%],p=0.303 [Cochran-Mantel-Haenszel test/TLOVR algorithm],incidence of protocol-defined virologic failure (5[3%] vs 6[3%]), non-significant difference), and change from baseline in median CD4+count (305 vs 302, non-significant difference). Drug-related grade 2–4adverse event frequency did not differ between groups betweenbaseline and week 144 (61[32%] vs 75[42%], p=0.675), althoughbetween Weeks 36 and 144 the abacavir/lamivudine+atazanavirsimplification group had a lower frequency of these adverse events(25[13%] vs 42[23%], p=0.015) and hyperbilirubinemia (12[6%] vs25[14%], p=0.023)(Fisher’s exact test) and was associated with morefavorable median changes in fasting lipids (mg/dL): total-cholesterol -10 vs. 3; HDL-cholesterol 3 vs. 3; LDL-cholesterol -4 vs. 0; andtriglycerides -42 vs. -11. CONCLUSION: Abacavir/lamivudine+atazanavir/ritonavir andabacavir/lamivudine+atazanavir simplification provided similar,sustained efficacy over 144 weeks, but the simplification arm wasassociated with a more favorable safety profile between Weeks 36 and144. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.

124E. Switch to Fosamprenavir with Addition of Lovaza forManagement of Hypertriglyceridemia in HIV-Infected Patients onBoosted Protease Inhibitor Regimens: A Pilot Study (BuLLET).Franco Felizarta, M.D.1, Anthony Scarsella, M.D.2, HomayoonKhanlou, M.D.3, John D. Stansell, M.D.4, Winston Young, B.S.5, LisaL. Ross, M.S.6, Henry Zhao, Ph.D.6, Keith A. Pappa, Pharm.D.6,Belinda F. Ha, Ph.D.6; (1)Franco Felizarta, M.D., Bakersfield, CA;(2)Pacific Oaks Medical Group, Beverly Hills, CA; (3)AIDSHealthcare Foundation, Los Angeles, CA; (4)Private Practice, PalmSprings, CA; (5)Statworks, Inc., Research Triangle Park, NC;(6)GlaxoSmithKline, Research Triangle Park, NC PURPOSE: Use of fish oil has been shown to reduce serumtriglyceride levels in HIV-infected patients receiving antiretroviraldrug therapy. Since management of hypertriglyceridemia requiresmultiple pharmacologic strategies, we examined the therapeutic effectof switching patients on boosted protease inhibitor (PI) regimens to aPI with fewer drug interactions and adding a prescription fish

oil/omega-3-acid ethyl ester formulation, Lovaza. METHODS: In this multicenter, 24-week study, 36 patients onboosted PI therapy with screening triglycerides 200–1,200 mg/dL,LDL-cholesterol ≤160 mg/dL, and HIV-1 RNA <50 c/mL, wereswitched to fosamprenavir 1400 mg plus ritonavir 100 mg once dailyat baseline. Lipid-lowering agents were discontinued at baseline andLovaza 4 g once daily was added at Week 6. RESULTS: 31 patients completed the study. Reasons fordiscontinuation were adverse events (2), non-compliance (1), loss-to-follow up (1), and protocol violation (1). Ten patients (28%) had adecrease in triglyceride levels between screening (≥200 mg/dL) andbaseline (<200 mg/dL). Median triglyceride concentration was 303mg/dL at screening, 262 mg/dL at baseline, 290 mg/dL at Week 6(+8%), and 218 mg/dL at Week 24 (-30% from Week 6). At Week 24,33% had triglycerides <200 mg/dL (intent-to-treat:missing-equals-failure analysis). Five patients (14%) had treatment-emergent grade2–4 adverse events. No serious adverse event was reported. MedianCD4 count increased by 55 cells/mm3 between baseline and Week 24.Among patients completing study, 100% (31/31) had HIV-1 RNA<400c/mL and 90% (28/31) had <50 c/mL at Week 24. One non-compliant patient experienced confirmed virologic failure (HIV-1RNA >400 copies/mL at or before Week 24) at Week 6. At time ofvirologic failure, no major treatment-emergent resistance-associatedmutations were detected in virus isolated from this patient. CONCLUSION: In this pilot study in boosted PI-treated HIV-infected patients with hypertriglyceridemia, switching tofosamprenavir 1400 mg plus ritonavir 100 mg once daily followed byLovaza reduced triglyceride levels while maintaining virologicsuppression. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.

125. Effects of Darunavir, Ritonavir and Darunavir/Ritonavir onT-Cell Activation and Apoptosis using HIV-negative CD4+Lymphocytes. James D. Scott, Pharm.D., MEd., B.S., Stephen A.O’Barr, Ph.D.; Western University of Health Sciences, Pomona, CA PURPOSE: Prior data from our group shows that treatment of HIV-negative CD4+ lymphocytes with LPV/r significantly increasesmitochondrial membrane integrity and that LPV or EFV alonesignificantly increases T-cell activation by almost 40%, as measuredby CD4 levels. RTV was also shown to increase CD4 labeling, though,at lower levels. In this study we hypothesized that darunavir/ritonavir(DRV/r) would result in T-cell activation and changes in apoptoticmarkers. METHODS: 24cc of blood was drawn from 15 HIV-negativecontrols. Peripheral Blood Lymphocytes were washed and sub-cultured, then activated with IL-2. Cells were then exposed to 3.5uMand 10uM DRV, 1.0 uM RTV, 3.5 uM DRV/1 uM RTV, and 10 uMDRV/1 uM RTV for 72 hours, or unexposed for control. Cells werestained with fluorochrome-tagged monoclonal antibody to CD4,CD38, CD69, CD127, and HLA-DR. Analysis of surface markerintensity was performed by flow cytometry, gated against CD4.Apoptosis was assessed by measuring JC-1 aggregates (mitochondrialmembrane integrity assay), caspases 3, 7, & 8 activity and TUNNELstaining (DNA integrity). RESULTS: Treatment with RTV alone (P<0.01), and both doses ofDRV/r (P<0.05), significantly increases HLA-DR expression(50–70%), compared with control. No change in HLA-DR was seenwith DRV alone. There was a significant difference in HLA-DRexpression between cells treated with RTV alone and DRV alone(P<0.05). While there were no statistically significant changes inCD38, 69, and 127 levels, substantial increases in CD69 expressionwere observed in RTV alone and DRV/r treated cells (20–25%). Notreatments significantly altered markers of apoptosis. CONCLUSION: RTV alone, and both doses of DRV/r, but not DRValone, activated CD4+ T-cells as measured by significant increases inHLA-DR expression. Similar trends were seen in CD69 levels. Thisdata complements our previous findings with LPV and EFV andsuggest that other antiviral drugs may enhance T-cell activation inHIV-negative CD4+ lymphocytes.

126E. Changes in Inflammatory Biomarker Levels andCorrelation with Framingham (FRAM) Risk Scores in

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Antiretroviral-Naive HIV-infected Patients through 144 Weeks ofAbacavir/Lamivudine-containing Therapy in ARIES(EPZ108859). Benjamin Young, M.D., Ph.D.1, Kathleen E. Squires,M.D.2, Lisa L. Ross, M.S.3, Lizette Santiago, M.D.4, Louis M. Sloan,M.D.5, Henry Zhao, Ph.D.3, Brian C. Wine, M.S.3, Margaret W.Schultz, M.S.3, David A. Margolis, M.D.3, Mark S. Shaefer,Pharm.D.6; (1)Division of General Internal Medicine, University ofColorado, Denver, CO; (2)Thomas Jefferson University, Philadelphia,PA; (3)GlaxoSmithKline, Research Triangle Park, NC; (4)HOPEClinical, San Juan, PR; (5)North Texas IDC, Dallas, TX; (6)ViiVHealthcare, Research Triangle Park, NC PURPOSE: Chronic inflammation is believed to increasecardiovascular disease (CVD) risk. In addition to traditional FRAM-defined CVD risk factors, CVD risk has been linked with elevations inthe inflammatory biomarkers Lp-PLA2, interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hs CRP). METHODS: In ARIES, 517 North American antiretroviral-naïvepatients, including those with high CVD risk, receivedabacavir/lamivudine+atazanavir/ritonavir for 36 weeks, then wererandomized 1:1 to either maintain or discontinue ritonavir for 108subsequent weeks. CVD risk and inflammatory biomarkerconcentrations were evaluated combining data from ritonavir-boostedand non-boosted dosing periods. FRAM 10-year risk groups (<6% or≥6%) were assigned at baseline. Concentrations of hsCRP, IL-6 andLp-PLA2 were assessed at baseline and Week 144. RESULTS: At Week 144, 93% of patients with biomarkerassessments had an HIV-1 RNA <50 c/mL. Median (Q1–Q3) hsCRP(mg/L) in patients with a FRAM 10-year CHD risk score <6% did notdiffer significantly (Wilcoxon signed-rank test) between baseline (1.6(0.6–3.4) [n=285]) and Week 144 (1.4 (0.6–3.4) [n=249])(p=0.535),nor did it for patients with a score ≥6% (1.9 (0.9–2.8) [n=61] vs 2.0(1.2–5.0 [n=50]) (p=0.102). Median (Q1-Q3) IL-6 (pg/mL) in patientswith a FRAM 10-year CHD risk score <6% was similar at baseline(1.6 (1.0-2.5)[n=287]) and Week 144 (1.4 (0.9–2.3) [n=249])(p=0.267), as was the case with patients with scores ≥6% (2.0(1.3–2.6) [n=61] vs 2.2 (1.5–3.5)[n=50]) (p=0.099). Conversely,median (Q1-Q3) Lp-PLA2 (nmol/min/mL) in patients with a FRAM10-year CHD risk score <6% significantly (p<0.001) decreasedbetween baseline (197 (162–238)[n=284] and Week 144 (168(138–198)[n=249], as it did even more for patients with scores ≥6%(238 (166–250)[n=60] vs 175 (147–213)[n=50]). CONCLUSION: In antiretroviral-naïve patients onabacavir/lamivudine-containing treatment, inflammatory biomarkerlevels generally correlated with the FRAM risk score. Betweenbaseline and Week 144, hsCRP and IL-6 did not change, but Lp-PLA2levels decreased significantly in both <6% and ≥6% risk-score groups. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.

Infectious Diseases

127. Candidemia Pharmacotherapy Over Eight Years at a TertiaryMedical Center. Thy Le, Pharm.D.1, Jason C. Gallagher, Pharm.D2;(1)Temple University Hospital, Philadelphia, PA; (2)TempleUniversity School of Pharmacy, Philadelphia, PA PURPOSE: We describe the characteristics, risk factors, choice ofantifungal therapy, and outcomes of patients with candidemia over aneight-year period. METHODS: This was a retrospective cohort study of patients ≥18years old hospitalized for ≥48 hours with candidemia treated withantifungal therapy from 2003–2010. Data collected includeddemographics, risk factors for candidemia, microbiology andlaboratory data, and antifungal therapy. APACHE II and Charlsonscores were calculated. Empiric and definitive antifungal therapy wasassessed for appropriateness. Inappropriate antifungal therapy wasdefined as use of fluconazole for C. krusei, or doses of fluconazole<800 mg per day for C. glabrata.RESULTS: A total of 181 charts were reviewed (55% male, mean age56±17, 11% immunocompromised). Common candidemia risk factorsincluded: prior antibiotic therapy (89%), presence of central venouscatheter (71%), mechanical ventilation (53%), and parenteral nutrition(49%). C. albicans was the most common species (38%) followed byC. glabrata (34%), and C. parapsilosis (16%). The mean length of

treatment was 15±9 days. Average APACHE II score was 17±10 andaverage Charlson score was 3.6±3.3.

2003 2004 2005 2006 2007 2008 2009 2010 Infections (n) 9 10 21 8 39 28 40 26 Initial Therapy (%)

Fluconazole 56 70 66 50 30 43 47.5 42 Echinocandin 44 30 34 50 69 57 52.5 58 Appropriate 67 60 66 62.5 79 86 77.5 88

Definitive Therapy (%) Fluconazole 33 80 43 37.5 41 54 60 38.5 Echinocandin 67 20 57 62.5 59 46 35 50 Other 5 12 Appropriate 100 80 95 87.5 89 93 75 92 Microbiological cure 100 100 95 87.5 89 79 87.5 85 Positive clinical outcome 67 80 62 62.5 56 50 70 69

CONCLUSIONS: Microbiological and clinical outcomes remainedconsistent over time despite improvement in rates of appropriate initialantifungal pharmacotherapy.

128E. Predictors of mortality among elderly patients with Gram-negative bloodstream infection. Travis Ledford, Pharm.D./MSCR,Candidate1, Chad Cannon, Pharm.D./MSCR, Candidate1, John B.Hughes, Pharm.D./MSCR, Candidate1, Christopher D. Pfeiffer, M.D.,MHS2, Luke F. Chen, MBBS, M.P.H.2, Melissa Johnson, Pharm.D.,MHS3, Deverick Anderson, M.D., M.P.H.2; (1)Campbell UniversityCollege of Pharmacy & Health Sciences, Morrisville, NC; (2)DukeUniversity Medical Center, Durham, NC; (3)Duke University MedicalCenter and Campbell University College of Pharmacy & HealthSciences, Durham, NC PURPOSE: Gram-negative (GN) infections cause significantmorbidity and mortality among hospitalized patients. However,predictors of outcomes among elderly subjects with Gram-negativebloodstream infection (GNBSI) have not been well established. Thepurpose of this study was to investigate variables associated withmortality in these patients. METHODS: We conducted an IRB-approved retrospectiveobservational study to evaluate baseline clinical and microbiologicfactors associated with 30-day all-cause mortality among subjects ≥ 65years of age with GNBSI identified at 4 community hospitals affiliatedwith the Duke Infection Control Outreach Network (DICON) between1994 and 2003. Variables with p<0.2 in c2 analysis were furtheranalyzed using multivariable logistic regression. RESULTS: 237 subjects with GNBSI were identified (Mean age: 74yrs; 62% Male; 74% Caucasian). The most common pathogens wereE. coli (30%), P. (22%), spp. (24%), and Proteus spp. (7%). Fifteenpercent of subjects had organisms that were non-susceptible to ≥ 1antibiotic in ≥ 2 antimicrobial classes (MDR2), and 7% had isolatesnon-susceptible to ≥ 3 classes. The overall 30-day mortality was 37%.The table shows predictors that were significantly associated with 30-day mortality on multivariable regression. CONCLUSIONS: We identified several variables associated with 30-day mortality among elderly subjects with GNBSI, including: olderage (≥ 80 years) and multi-drug resistance.

Predictors of 30-Day Mortality in Subjects with GNBSI Variable Odds Ratio (95% CI) p-value

Age ≥ 80 years 2.52 (1.16–5.5) 0.0197

Vasopressors at baseline 3.12 (1.48–6.92) 0.0032

Pseudomonas spp. 2.27 (1.15–4.49) 0.0185

Proteus spp. 3.01 (1.01–8.98) 0.048

MDR2 2.19 (1.01–4.75) 0.0475

Diabetes mellitus 0.42 (0.19–0.91) 0.0273

Presented at 51st Interscience Conference on Antimicrobial Agents &Chemotherapy. Chicago, IL, September 17–20, 2011.

129. A comparison of patients with Klebsiella bacteremia withimipenem-resistance to those with 3rd generation cephalosporinresistance. Jason Gallagher, Pharm.D1, Prachi D. Bhatt, Pharm.D2,Elizabeth Marino, Pharm.D.3; (1)Temple University School ofPharmacy, Philadelphia, PA; (2)Temple University Hospital,Philadephia, PA; (3)Pennsylvania Hospital, Philadelphia, PA PURPOSE: Carbapenem-resistant (CR) Enterobacteriaceae are a


relatively recent phenomenon with few treatment options. The purposeof this study was to describe differences between third-generationcephalosporin-resistant (3GCR) and CR Klebsiella pneumoniaebacteremia in terms of outcomes. METHODS: This was a retrospective, cohort study. Patients wereidentified via the microbiology laboratory’s electronic record systemand included if they had a positive blood culture for K. pneumoniaeand were > 18 years old. Patients without clinical evidence ofinfection were excluded. Data on baseline characteristics, clinical andmicrobiologic success, and mortality was collected. RESULTS: A total of 464 patients were identified with blood culturespositive for K. pneumoniae from 2006–2011. 111 patients wereincluded in the 3GCR arm and 44 in the CR arm.

3GCR (n=111) CR (n=44) P value

Age, median (range) 56 (19-98) 57.5 (22-80) 0.915 Gender; Men (%) 60 (54) 20 (45) 0.4309 ICU Admissions, n (%) 65 (58.6) 34 (77) 0.0454 Presence of comorbidities, n (%) 89 (90) 40 (90) 0.168 Length of stay in days,

median (range) 47 (7-416) 44 (4-153) 0.25 APACHE II, median (range) 16 (4-35) 11 (2-26) <0.0001 Charlson index, median (range) 5 (0-14) 2 (0-11) <0.0001 ID Consult obtained n (%) 57 (51.4) 38 (86) 0.0001 Hospital Day of first (+) BCx,

median (range) 21 (1-205) 29.5 (1-181) 0.59 Microbiologic success, n (%) 101 (90.9) 27 (61) <0.0001 Clinical Success, n (%) 61 (55) 9 (20.5) 0.0002 Mortality at the end of therapy,

n (%) 31 (27.9) 24 (55) 0.0033CONCLUSIONS: CR K. pneumoniae bacteremia patients had worseoutcomes than those with 3GCR K. pneumoniae bacteremia, thoughbaseline characteristics seemed to indicate that they were less-ill.More investigation is required to determine why this is the case.

130. Mitochondrial toxicity with caspofungin. Kayla R. Stover,Pharm.D., BCPS1, Jonathan P. Hosler, Ph.D.2, John D. Cleary,Pharm.D.2; (1)The University of Mississippi School of Pharmacy,Jackson, MS; (2)University of Mississippi Medical Center, Jackson,MS PURPOSE: The echinocandins are a relatively new class ofantifungal agents. In previous ex vivo live-heart studies, caspofungin(CASP) was found to cause cardiac toxicity. Subsequent tissueevaluation by transmission electron microscope demonstrated possiblechanges in the mitochondria and muscle tissue. The purpose of thisstudy was to determine if CASP affects oxidative phosphorylation inmitochondria. METHODS: Isolated mitochondria studies were performed usingliver tissue from Harlan Sprague-Dawley Rats. Liver tissue (1 g) washomogenized and centrifuged with a sucrose mitochondrial extractionbuffer. Mitochondrial respiration was measured as O2 consumptionusing a Clark-type electrode in a 1.5 mL stirred vessel maintained at25oC, using 1 M glutamate/0.5 M malate or 0.5 M succinate assubstrates (S1). ADP (60 mM) or FCCP (75 uM) and valinomycin (3mM) (S2) were used to measure the states of respiration. Aftersubstrate baseline, CASP was added in exposure concentrationsranging from 4.9 to 70.94 ug/mL.RESULTS: At concentrations < 10 ug/mL, CASP increased oxygenconsumption from S1 baseline by 242.5 ± 13.5%. No change inoxygen consumption (3.1 ± 4.1%) was seen compared to S2 baseline.At concentrations > 10 ug/mL, decreases in oxygen consumption of75.8 ± 10.6% and 19.7 ± 35.1% were seen compared to S1 and S2baselines, respectively. CONCLUSION: CASP inhibits mitochondrial oxidativephosphorylation. The inhibition of Complex I, Complex II, ComplexIV, ATP synthase, the ATP-ADP translocase, and the transport ofglutamate, malate and succinate cannot be the sole source of theinhibition. CASP may act to inhibit Complex III, the import ofphosphate, or it may act as an inhibitor at multiple sites. Furtherstudies are necessary to test these and other possibilities.

131. A retrospective comparison of daptomycin thrice-weeklyversus Q48H dosing in hemodialysis patients with vancomycin-

resistant enterococcus or methicillin-resistant Staphylococcusaureus bacteremia. Katie L. Axford, Pharm.D., Dane L. Shiltz,Pharm.D., BCPS; Indiana University Health and Butler University,Indianapolis, IN PURPOSE: This study retrospectively assessed clinical andmicrobiological outcomes in hemodialysis patients with vancomycin-resistant enterococcus (VRE) or methicillin-resistant Staphylococcusaureus (MRSA) bacteremia treated with daptomycin thrice-weeklycompared to traditional Q48H dosing. METHODS: All patients with positive blood cultures who received atleast one dose of daptomycin between January 1st 2009 and December31st 2010 at Indiana University Health Methodist and UniversityHospitals were identified. Subjects age ≥ 18 years with end-stage renaldisease on a stable thrice-weekly hemodialysis regimen, confirmedVRE or MRSA bacteremia, and at least three doses of inpatientdaptomycin therapy on one of the study schedules were enrolled in thestudy. Data were obtained through a retrospective review of electronicmedical records. Microbiologic cure was assessed using time toclearance of blood cultures. Clinical indicators of infection, includingdaily maximum temperature (Tmax) and WBC count, were used toassess clinical cure. RESULTS: Twelve patients were identified who met criteria forinclusion in this study. Nine received daptomycin every 48 hours forthe treatment of bacteremia, and three received daptomycin thrice-weekly after dialysis. There was no difference in time to clearance ofblood cultures between the Q48H and thrice-weekly groups(2.11±2.15 days vs 4.33±4.16 days; p=0.241). No patients were febrileupon initiation of daptomycin, and only three patients in the Q48Hgroup had a clinically significant white blood cell count on initiationof daptomycin. Length of hospital stay was not statisticallysignificantly different between the two treatment regimens (22.8 daysvs 14.9 days; p=0.065). CONCLUSION: Thrice-weekly dosing of daptomycin may beeffective for the treatment of bacteremia in hemodialysis patients.Further research is needed to support the non-inferiority of thisregimen compared to Q48H dosing.

132. Assessment of fluoroquinolone-resistant urinary pathogens inpatients admitted to an acute care hospital from a nursing home.Brian R. Lohr, Pharm.D.; University of Pittsburgh Medical Center,Pittsburgh, PA PURPOSE: This study was conducted in order to measure rates offluoroquinolone resistance and determine empiric antibiotic therapyfor nursing home patients admitted to an acute care setting diagnosedwith a urinary tract infection (UTI). Initiating appropriate antibiotictreatment for nursing home patients is essential to improve clinicaloutcomes. METHODS: Medical records of 105 nursing home patients admittedthrough the emergency department were retrospectively reviewedfrom April 2009 to December 2009. Diagnostic codes were used todetermine the presence of UTIs during their hospitalizations. Urinecultures with corresponding susceptibilities to ciprofloxacin wereevaluated and data was collected for 159 total urinary isolates.Susceptibility results were recorded as susceptible, intermediate, orresistant. Choice of empiric antibiotic therapy was also recorded forfluoroquinolone-resistant pathogens. RESULTS: Of the 159 urinary pathogens reported, 60% weresusceptible, 1% intermediate, and 39% resistant to ciprofloxacin.E.coli susceptibility to ciprofloxacin was 54.1% in this study. Incontrast, E.coli susceptibility to ciprofloxacin for all patients at ourinstitution was 73%, as documented by an antibiogram during asimilar time period. Appropriate antibiotic therapy was delayed anaverage of 47.3 hours in 9 nursing home patients; these patients wereinitiated on a fluoroquinolone while infected with a fluoroquinolone-resistant urinary pathogen. CONCLUSION: Due to the resistance rates observed in this study,antibiotics other than fluoroquinolones, such as cephalosporins andsulfamethoxazole-trimethoprim, should be considered for the empirictreatment of UTIs in nursing home patients. Clinical judgment andlocal susceptibility rates should also play a role when initiatingantibiotic therapy for these patients.

133. Evaluation of antibiotic prescribing patterns in patients

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receiving sustained low-efficiency dialysis. Laura E. Harris,Pharm.D.1, Anne Reaves, Pharm.D.1, Amy Krauss, Pharm.D.1, JustinGriner, BS2, Joanna Q. Hudson, Pharm.D.2; (1)Methodist UniversityHospital, Memphis, TN; (2)The University of Tennessee College ofPharmacy, Memphis, TN PURPOSE: Sustained low-efficiency dialysis (SLED) is a new“hybrid” form of continuous renal replacement therapy that isbecoming increasingly popular; however, there is very limitedinformation on drug disposition during this procedure. The purpose ofthis study was to evaluate prescribing patterns for specified antibioticsfor patients requiring SLED at our institution. METHODS: A retrospective review was performed for patients whoreceived concurrent SLED and antibiotic therapy from January2009–January 2011. Demographic data, prescribed antibiotic dosingregimens, and doses delivered as prescribed were determined.Antibiotics of interest included cefepime (C), daptomycin (Da),doripenem (D), gentamicin (G), Imipenem-cilastatin (I), linezolid (L),meropenem (M), piperacillin-tazobactam (P), tobramycin (T), andvancomycin (V). Dosing regimens were compared torecommendations from the literature when available. The incidence ofclinical and microbiologic cure was also evaluated. RESULTS: 87 patients met inclusion criteria: mean age 54±14 yrs,60% male, 58% Caucasian. The total number of orders for eachantibiotic was: C (n=14), (n=27), D (n=35), G (n=0), I (n=18), L(n=34), M (n=27), P (n=71), T (n=0), V (n=27). Antibioticprescriptions were evidence-based for 37% of , 3% of L, 14% of M,and 7% of V. The majority of discrepancies were due to doses lowerthan recommended. On average 13% of antibiotic doses were missed:11% of C, 12% of , 10% of D, 12% of I, 6% of L, 8% of M, 14% of P,and 28% of V orders. Of the 13 patients who met inclusion criteria toevaluate clinical and microbiologic cure, 10 had a microbiologic cureand no patient achieved clinical cure. CONCLUSIONS: Prescribed antibiotic dosing regimens variedsubstantially and under-dosing was common. There is a need to furtherevaluate antibiotic prescribing in the SLED population to ensureappropriate therapy.

134. Identifying an optimal dose of vancomycin in morbidly obesepatients. Gary N. Elsasser, Pharm.D.1, Phillip S. Lorhan, Pharm.D.2,Christopher J. Destache, Pharm.D., FCCP1; (1)Creighton UniversitySchool of Pharmacy and Health Professions, Omaha, NE;(2)Creighton University Medical Center, Omaha, NE PURPOSE: To determine the dose (mg/kg) of vancomycin necessaryto achieve a therapeutic trough concentration (10-20 mcg/ml) inmorbidly obese patients and whether differences exist in non-obese,overweight, obese and morbidly obese patients. METHODS: We retrospectively reviewed the electronic records of alladult (≥19 years) patients admitted to our hospital between January 1,2007 and December 31, 2010 and prescribed vancomycin for aminimum of 24 hours. Non-pregnant patients with at least onevancomycin trough concentration obtained at steady state, a creatinineclearance of ≥ 60 ml/min and a stable serum creatinine were includedfor analysis. Patients were then subdivided into one of four groupsrelative to their body mass index (BMI); Group I – BMI = 18.5–24.9,Group II – BMI 25–29.9, Group III – BMI 30–39 and Group IV ≥ 40.Each group was compared using ANOVA for continuous variableswith Bonferroni post-hoc testing for continuous data. An a priori levelof significance was set at a p value of ≤ .05. RESULTS: Of 1709 patients screened, 141 were included in theanalysis (27, 38, 47, 29; Groups I–IV, respectively). There were nostatistically significant differences with respect to age, gender, height,creatinine clearance, or length of hospital stay between the fourgroups. Mean (± S.D.) vancomycin dose producing a therapeutictrough was significantly less in Group IV (12.4 mg/kg ± 2.38,p=0.002) versus all other groups (14.8 ± 2.76, 14.4 ± 2.1, 14.1 ± 2.48,groups I-III, respectively). CONCLUSION: Morbidly obese patients with normal renal functionrequired a significantly less mg/kg dose of vancomycin to produce asimilar therapeutic trough concentration as compared to their obeseand non-obese counterparts.

135. Pseudomonas aeruginosa (PSA) combination antibiogram:incorporating pharmacodynamic breakpoints (PDB) to identify

most appropriate empiric regimens. Kathy Zhang, Pharm.D.,Candidate, Gregory A. Eschenauer, Pharm.D., Brian A. Potoski,Pharm.D.; University of Pittsburgh Medical Center, Pittsburgh, PA PURPOSE: Inappropriate empirical antibiotic therapy for PSAinfections has been shown to result in increased mortality.Combination antibiograms for PSA have been shown to be helpful inidentifying the most appropriate empirical therapy regimen. However,such studies have not yet incorporated minimum inhibitoryconcentrations (MICs) in their analyses. Inclusion of such data mayresult in more robust recommendations, given data showing decreasedefficacy of certain antibiotics as MICs increase. As appropriateness forsome agents may depend on the MIC even when in the susceptiblerange, we devised a combination antibiogram which incorporatesPDB. METHODS: A query of the hospital microbiology database wasmade for PSA isolates identified from blood or respiratory tract sitesin three intensive care units between 1/1/2009 and 12/31/2010.Duplicates, defined as isolates from the same source within 7 days ofthe index culture, were excluded. Susceptibilities and MICs wererecorded. PDB, i.e., MICs above which outcomes may be expected tosuboptimal, were defined as follows: cefepime (CPM) 4 µg/mL;piperacillin/tazobactam (P/T) 16 µg/mL; meropenem (M) 2 µg/mL,ciprofloxacin (C) 0.25 µg/mL; amikacin (A) 4 µg/mL; andgentamicin/tobramycin (G/T) 2 µg/mL. RESULTS: 376 isolates were included. Incorporation of PDB into theantibiogram resulted in substantial changes in likelihood ofappropriate therapy: Likelihood of Appropriate Empiric PSA Therapy (%)

PDB Not Incorporated PDB Incorporated Single Agents CPM 70 38 M 68 63 P/T 67 58 C 71 51

T Combinations CPM+T 91 77 M+T 90 82 P/T+T 92 84 C+T 91 80

C Combinations CPM+C 84 57 M+C 82 71 P/T+C 85 70

CONCLUSION: At our institution, incorporation of PDB resulted indramatic changes in CPM susceptibility, such that non-standard PD-based dosing is now being evaluated for empiric use. Incorporation ofPDB is necessary to properly inform choices of empiric antibioticcombinations targeting PSA.

136. The impact of a gentamicin-citrate catheter lock interventionon outpatient hemodialysis catheter-associated bloodstreaminfections. Christine Hamby, Pharm.D.1, Kristen Buczynski,Pharm.D., Candidate1, Michelle Vignari, RN, CIC., A.A.S.1, MiyakoNewell, B.S.N.1, Donna Farnsworth, R.N., M.H.A., C.I.C.2, StephenSilver, M.D.1, Edward Walsh, M.D.1, Alexandra Yamshchikov, M.D.1;(1)Rochester General Hospital, Rochester, NY; (2)Unity HealthSystem, Rochester, NY PURPOSE: Central line associated blood stream infection (CLABSI)is a major contributor to morbidity and mortality in patients dialyzedvia a central venous catheter (CVC). Short-term studies usingantimicrobial-anticoagulant lock solutions have demonstratedreductions in CLABSI. We investigated the impact of a GC (1 mg/mlGentamicin + 4% Citrate) lock to reduce CLABSI rates over 2-years,and its effects on access function and patterns of bacterial resistance. METHODS: Intradialytic locking of dialysis catheters with GCsolution replaced heparin for all RGHS patients receiving dialysis viaCVCs from January 2009 to January 2011. CLABSI rates, alteplaseuse to maintain CVC patency, and incidence of gentamicin resistantbacteremias were compared for 24 months pre and post interventionusing unpaired t-test. RESULTS: During the 2-year intervention period, a quarterly averageof 326 + 22 dialysis patients with CVCs were treated with the GClock. There was a 77% reduction in CLABSI rates compared to


baseline (0.5 + 0.2 infections/1000 catheter days vs. 2.1 + 0.5infections/1000 catheter days, p < 0.0005). No change in access-associated bacteremia was observed for patients dialyzed via fistulaeor grafts. Alteplase use did not change significantly during theintervention (27 + 5.7 treatments/ 1000 catheter days vs. 30.2 + 5.5treatments/1000 catheter days). Gram positive bacteria caused 71/152(47%) CLABSI during the pre-GC period and 40/41 (98%) post-GC.Although no significant increase in enterococcal CLABSI was notedduring the intervention period (14.6% vs. 16%) a significant increasein gentamicin resistance of enterococcal CLABSI isolates wasobserved post intervention (83% vs. 12% resistance at baseline). CONCLUSION: Introduction of a GC intradialytic lock has resultedin a 77% reduction in CLABSI rates for patients dialyzed via a CVC.Although no significant impact on catheter function was observed,emergence of gentamicin resistance in enterococcal CLABSI isolatesdoes merit further study.

137E. Impact of NXL104 on ceftaroline MICs for bacteriaproducing extended-spectrum, AmpC, or KPC b-lactamases.Robert E. Badal, B.S.1, Samuel Bouchillon, M.D.1, Meredith Hackel,Ph.D.1, Daryl Hoban, Ph.D.1, Christine Lascols, M.S.1, StephenHawser, Ph.D.2, Gregory Williams, Ph.D.3; (1)International HealthManagement Associates, Inc, Schaumburg, IL; (2)IHMA Europe Sárl,Epalinges, Switzerland; (3)Cerexa, Inc. (a wholly owned subsidiary ofForest Laboratories, Inc., New York, NY), Oakland, CA PURPOSE: Ceftaroline (CPT) is a broad-spectrum cephalosporinwith activity against resistant gram-positive and common gram-negative pathogens. Like other cephalosporins, its activity issignificantly reduced by extended-spectrum b-lactamases (ESBL),AmpC enzymes, or KPCs. NXL104 (NXL) is a non-b-lactam b-lactamase inhibitor that enables in vitro activity of many β-lactamsagainst these b-lactam-resistant isolates. We evaluated MICs of CPTwith and without NXL against a collection of molecularly-characterized b-lactamase-producing Enterobacteriaceae (ENT). METHODS: Susceptibility of 816 recent clinical ENT isolatespreviously shown to produce ESBL enzymes (including 6 TEM, 14SHV, and 20 CTX-M variants), AmpC (10 variants), or KPC (4variants) to CPT and CPT + NXL (CXL) was determined using brothmicrodilution panels in accordance with CLSI guidelines. MICs ofCPT were compared to those of CXL and the magnitude of MICreduction was calculated. RESULTS: See table.

CPT CXL Reduction inEnzyme Profile (N) MIC50/90 MIC50/90 CPT MIC90

CTX-M (538) >32/>32 £0.06/0.25 ≥256-fold KPC (118) >32/>32 1/2 ≥32-fold SHV (50) >32/>32 £0.06/0.5 ≥64-fold AmpC + CTX-M (43) >32/>32 0.25/2 ≥32-fold SHV + CTX-M (28) >32/>32 £0.06/0.25 ≥256-fold SHV + KPC (18) >32/>32 1/4 ≥16-fold TEM (7*) [4->32] [£0.06-0.5] * TEM + CTX-M (6*) [>32] [£0.06-0.5] * AmpC + SHV (5*) [4->32] [£0.06-0.5] * SHV + TEM (1*) [32] [0.12] * AmpC + TEM (1*) [>32] [0.5] * AmpC + SHV + CTX-M (1*) [>32] [0.5] **MIC50/90 not calculated if N<10; instead, MIC range is shown in brackets. CONCLUSIONS: NXL lowered CPT MIC90s from ≥16 to ≥256-foldfor all variants and combinations of b-lactamases, and lowered MICsby a minimum of 16-fold against KPC-producing isolates. CXL, thecombination of NXL with CPT, promises to expand the spectrum ofactivity of CPT to include b-lactamase-producing ENT. Presented at Presented at the 50th Annual Interscience Conference onAntimicrobial Agents and Chemotherapy, Boston, MA, September12–15, 2010.

138. New dosing recommendations for vancomycin in prematureinfants. Eric B. Hoie, Pharm.D., Justin Tolman, Pharm.D., Ph.D.;Creighton University School of Pharmacy and Health Professions,Omaha, NE PURPOSE: Vancomycin is a commonly used antibiotic in prematureinfants for suspected or proven Staphylococcal infections. Current

dosing guidelines are generally insufficient if trough concentrations of15 mg/L are desired. New dosing recommendations are needed toachieve trough concentrations of 15 mg/L METHODS: Using previously published pharmacokineticparameters, dosing guidelines for vancomycin needed to achievetrough concentrations of 15 mg/L will be determined for two groups ofpremature infants; infants less than 36 weeks post-conceptual age(group 1) and infants greater than or equal to 36 weeks post-conceptual age (group 2). These dosing guidelines will be applied toestimate peak and trough concentrations in premature infants at ourinstitution who have received a minimum of three vancomycin dosesand had pharmacokinetic parameters calculated using peak and troughconcentrations. RESULTS: Nine infants, four in group 1 and five in group 2, hadpeak and trough concentrations measured on twelve courses ofvancomycin. The mean trough concentrations were 8.05 and 8.97mg/L in groups 1 and 2 respectively. CONCLUSION: Current dosing recommendations for vancomycinin premature infants do not produce the recommended troughconcentrations of 15 mg/L. New dosing recommendations will beprovided to achieve this recommended trough.

139E. Spectrum of activity of ceftaroline/NXL104 and b-lactamcomparator agents tested against methicillin-resistantStaphylococcus aureus carrying different SCCmec types andgram-negative bacilli with well-characterized resistancemechanisms. David J. Farrell, Ph.D.1, Rodrigo E. Mendes, Ph.D.1,Gregory Williams, Ph.D.2, Ian Critchley, Ph.D.2, Ronald N. Jones,M.D.1, Helio S. Sader, M.D., Ph.D.1; (1)JMI Laboratories, NorthLiberty, IA; (2)Cerexa, Inc. (a wholly owned subsidiary of ForestLaboratories, Inc., New York, NY), Oakland, CA PURPOSE: To determine the spectrum of activity and potency ofceftaroline combined with NXL104 (fixed 4 mg/L; CPT104) andcomparators against selected MRSA (different types) and Gram-negative strains harbouring different b-lactamase (BL)-encodinggenesCeftaroline is a broad-spectrum cephalosporin with activityagainst resistant Gram-positive and common Gram-negativeorganisms and limited activity against extended-spectrum b-lactamase(ESBL)- and -producing strainsNXL104 is a novel non-b-lactam BLinhibitor that inhibits Ambler class A, C, and D enzymes. METHODS: Susceptibility testing was performed by CLSI brothmicrodilution on 250 strains as follows: MRSA (100 subcategorizedby type; E-ESBL (50 Enterobacteriaceae [ENT] with ); E-

MIC50/MIC90 (mg/L) Antimicrobial E-ESBL E-AMPC E-CARB

Ceftaroline >64/>64 32/>64 >64/>64 CPT104a 0.06/0.25 0.12/0.5 0.5/2 Ceftazidime >16/>16 >16/>16 >16/>16 P/T 32/>64 32/>64 >64/>64 Imipenem 0.12/0.5 0.5/1 8/>8 reported refer to CPT concentration.RESULTS: All MRSA, except one, were inhibited at ≤2/4 mg/L ofCPT104CPT104 was also very active against the variety of ENT (E-ESBL, E-AMPC, and E-CARB; highest MIC, 4 mg/L)AlthoughCPT104 demonstrated activity against wild-type ACB and PSA,activity was low against BL-producing strainsCeftazidime andpiperacillin/tazobactam (P/T) were inactive against allcategoriesImipenem had activity against E-ESBL and E-AMPC butlimited or no activity against other categories. CONCLUSIONS: CPT104 was very active against MRSAregardless of type/subtype and ENT regardless of BL type, but hadlimited intrinsic activity against ACB and PSA expressing . CPT104had a wider spectrum of activity against these resistant Gram-positiveand -negative categories than the comparatorsCPT104 represents apotential therapeutic option for empiric therapy in settings whereMRSA and BL-positive ENT predominate. Presented at Presented at the 20th Annual European Congress ofClinical Microbiology & Infectious Diseases, Vienna, Austria, April10–13, 2010.

140E. Antimicrobial activity of ceftaroline combined with NXL104tested against a collection of organisms expressing multiple b-

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lactamases. Helio S. Sader, M.D., Ph.D.1, Gregory Williams, Ph.D.2,Gary J. Moet, B.S.1, Mariana Castanheira, Ph.D.1, Ian Critchley,Ph.D.2, Ronald N. Jones, M.D.1; (1)JMI Laboratories, North Liberty,IA; (2)Cerexa, Inc. (a wholly owned subsidiary of Forest Laboratories,Inc., New York, NY), Oakland, CA PURPOSE: To evaluate the activity of ceftaroline combined withNXL104 (fixed 4 mg/L; CPT104) against Enterobacteriaceae (ENT)with various types of β-lactamases (BL). Ceftaroline is a broad-spectrum cephalosporin with activity against resistant Gram-positiveand common Gram-negative organisms and limited activity againstextended-spectrum β-lactamase (ESBL)- and AmpC-producingstrains. NXL104 is a novel non-β-lactam BL inhibitor that inhibitsAmbler class A, C, and D enzymes. METHODS: CPT104 and comparators were tested for susceptibility(S) by CLSI broth microdilution against 148 clinical strains of ENTproducing KPC + AmpC (n=26), ESBL + AmpC (n=27), KPC +ESBL (n=7), multiple ESBLs (n=37), SME or NMC-Acarbapenemases (n=7), KPC (n=12), CTX-M (n=9), plasmidic AmpC(n=15), and metallo-BL (MBL; n=8). Isolates were collected fromglobal surveillance programs (1998-2008). RESULTS: CPT104 exhibited potent inhibitory effects against all BLtypes except MBLs; all isolates were inhibited at MICs £4 mg/Lexcept MBL-producing strains. CPT104 was highly active againstENT producing KPC (MIC90, 0.5 mg/L), KPC + AmpC (MIC90, 2mg/L), and KPC + ESBL (MIC100, 1 mg/L). CPT104 was more activethan meropenem (MIC90, >8 mg/L) against these 3 groups. ENT-producing CTX-M (highest CPT104 MIC, 0.5 mg/L) and thoseproducing more than one ESBL type (MIC90, 1 mg/L) were also veryS to CPT104. The highest CPT104 MIC observed among plasmidicAmpC was 0.5 mg/L. All strains producing SME or NMC-A were alsoinhibited at £0.5 mg/L of CPT104. CPT104 and all β-lactams testedshowed limited activity against MBL-producing ENT. CONCLUSIONS: NXL104, combined with ceftaroline, lowersceftaroline MIC for ENT that produce the most clinically significantBLs, except MBLs. CPT104 was active against ENT producing KPC,various ESBL types, and AmpC, as well as those producing more thanone of these BL types. CPT104 represents a promising therapeuticoption for infections caused by multidrug-resistant ENT. Presented at Presented at the 20th Annual European Congress ofClinical Microbiology & Infectious Diseases, Vienna, Austria, April10–13, 2010.

141E. Ertapenem monotherapy versus cefotetan/metronidazolecombination therapy in colorectal surgery patients. Noreen H.Chan-Tompkins, Pharm.D., Valerie Vuylsteke, Pharm.D., Sunil Bhat,M.D., David Medich, M.D.; Allegheny General Hospital, Pittsburgh,PA PURPOSE: Cefotetan, cefoxitin, or ertapenem are considerations forcolorectal surgical prophylaxis. The primary objective was to comparethe efficacy of combination therapy (cefotetan [or cefoxitin] andmetronidazole) versus monotherapy (ertapenem) for surgicalprophylaxis in patients undergoing colorectal surgery. The secondaryobjective was to compare post-surgical infection outcomes stratifiedby body mass index (BMI). METHODS: The institutional review board approved thisretrospective cohort study for colorectal surgeries between7/1/07–6/30/09. Additional inclusion criteria: ages 18–89 years,prophylaxis with combination or monotherapy. Exclusion criteria:pregnancy, rectal only surgery, perforation/leak during surgery, post-operative antibiotics for other infections. Post-operative infectionincidence was compared using logistic regression model. RESULTS: Of 260 patients screened, 110 patients met criteria(combination, n=52 vs. monotherapy, n=58). For the combination andmonotherapy group respectively, baseline characteristics: mean agewas 58.5+16.5 vs. 56.4+18.1 years; male 54% vs. 57%; mean BMI27.3+5.0 vs. 26.4+6.3; cardiovascular disease 48% vs. 45%;malignancy 17% vs. 29%; diabetes 11% vs. 10%; albumin<3.5 g/dL8% vs. 9%; chronic corticosteroid therapy 2% vs. 9%; mean length ofhospital stay 6.6+2.3 days vs. 6.7+2.5 days (p>0.05 for baselinecharacteristics). Post-operative prophylactic antibiotics were given in19% of patients in both groups. In the combination vs. monotherapygroup respectively, prophylaxis success (defined as no surgicaldrainage at 30+7 days post-colorectal surgery) was 80% vs. 89%

(p=0.693); surgical site drainage (drainage from surgical incision at30+7 days post-colorectal surgery) was 20% vs. 11% (p=0.639);surgical site infection was 9% vs. 7% (p=0.8836). For combinationand monotherapy respectively, prophylaxis success stratified by BMI<30 was 83% vs. 87% (p=0.3752); BMI > 30 was 73% vs. 91%(p=0.9178). CONCLUSION: The incidence of post-operative infections waslower in the ertapenem monotherapy compared to combinationtherapy (cefotetan [or cefoxitin] and metronidazole), regardless ofBMI, although statistical significance was not noted. Largerprospective studies are warranted. Presented at Presented as poster presentation at the American Societyof Health-System Pharmacists Midyear Clinical Meeting, Anaheim,CA, December 5–9, 2010.

142. Treatment of urinary tract infections: are cephalosporinsassociated with failure?Jeffrey A. Starkey, Pharm.D., Jeff R Hurren, Pharm.D., Rachel MChambers, Pharm.D., Susan L. Davis, Pharm.D.; Henry Ford Hospital,Detroit, MI PURPOSE: Urinary tract infections (UTI) are a frequent cause ofmorbidity in the United States, resulting in millions of office visits andthousands of hospitalizations each year. The objective of this studywas to compare retreatment rates of urinary tract infections treatedwith cephalosporins versus non-b-lactam (NBL) antibiotics. METHODS: Restrospective cohort study including patientsdiagnosed and treated for an uncomplicated UTI, complicated UTI, orpyelonephritis between July 31, 2010 and October 31, 2010.Outcomes were evaluated if patients were treated for a gram-negativeUTI meeting prespecified diagnostic criteria and received either acephalosporin or a NBL such as trimethoprim/ sulfamethoxazole or afluoroquinolone. Other data collected included patient demographics,antibiotic regimen and duration, and comorbid conditions. RESULTS: 87 patients were included. Patients receivingcephalosporins were numerically more likely to be older (78 yr vs 55yr median age), male (42% vs 14%), have pyelonephritis (22% vs12%) or a complicated UTI (47% vs 25%) than uncomplicated UTI(31% vs 64%) compared to those receiving NBL. Organisms isolated:E. coli (61/87; 70%), P. mirabilis (9/87; 10%), Enterobacter spp.(8/87; 9%) and other (9/87; 10%). Retreatment for urinary tractinfection within 30 days:

Cephalosporins

n=36 NBL n=51 p-value

Retreatment, overall 0/36 (0%) 3/51 (5.9%) p=0.264 Retreatment,

susceptible organism 0/35 (0%) 1/48 (2.1%) p=1.000CONCLUSIONS: Treatment with cephalosporin agents was notassociated with a higher proportion of therapeutic failure whentreating urinary tract infections. Treatment of urinary tract infectionswith cephalosporin agents may be appropriate when supported bylocal resistance patterns.

143. Pharmacokinetics and pharmacodynamics ofpiperacillin/tazobactam administered by prolonged infusion inmorbidly obese, hospitalized patients. S. Christian Cheatham,Pharm.D.1, Megan R. Fleming, Pharm.D.1, Daniel P. Healy, Pharm.D.2,Christina E. K. Chung, Pharm.D.3, Katherine M. Shea, Pharm.D.4,Melissa L. Humphrey, Pharm.D. Candidate5, Michael B. Kays,Pharm.D.3; (1)St. Francis Hospitals and Health Centers, Beech Grove,IN; (2)James Winkle College of Pharmacy, University of Cincinnati,Cincinnati, OH; (3)Purdue University College of Pharmacy,Indianapolis, IN; (4)University Medical Center at Brackenridge,Austin, TX; (5)Purdue University College of Pharmacy, WestLafayette, IN PURPOSE: To evaluate the PK/PD of piperacillin/tazobactam(PIP/TAZ) when administered by prolonged infusion (PI) in morbidlyobese patients. METHODS: Hospitalized patients with a BMI > 40 kg/m2 receivedPIP/TAZ 6.75 g q8h (n=10) or 4.5 g q8h (n=2), infused over 4 h.Serial blood samples were collected at steady-state, and PIP/TAZconcentrations were determined by HPLC. PK parameters wereestimated, and 5,000-patient Monte Carlo simulations were performedto estimate PIP PK profiles for 4 PI regimens: 3.375 g q8h, 4.5 g q8h,


6.75 g q8h, and 9.0 g q8h. Probability of target attainment (PTA) for ≥50% 64 RESULTS: Patient demographics were (mean ± SD): age 48 ± 11years; weight 168 ± 26 kg; BMI 57.4 ± 15.1 kg/m2. For PIP and TAZ,mean ± SD elimination rate was 0.424 ± 0.186 h-1 and 0.302 ± 0.114 h-

1, mg/ml. Only 9.0 g q8h achieved a PTA > 90% at an MIC of 32mg/ml. CONCLUSIONS: PIP and TAZ pharmacokinetics are altered inmorbidly obese patients when compared to non-obese patients.Therefore, larger doses are required in morbid obesity to achievesimilar exposures to non-obese patients. PI doses of 4.5 g and 6.75 gq8h in morbidly obese patients provides comparable PD exposures to3.375 g and 4.5 g q8h, respectively, in non-obese patients.

144. Influence of Serum and Albumin on EchinocandinPharmacodynamics. Aasya S. Nasar, Pharm.D. , Nathan P.Wiederhold, Pharm.D.; University of Texas at Austin College ofPharmacy, San Antonio, TX PURPOSE: The Clinical Laboratory and Standards Institute (CLSI)has proposed lowering echinocandin Candida breakpoints. Analternative to this change that has been proposed is the addition ofeither human serum or albumin to the growth medium due to theextensive protein binding observed with these antifungals. Ourobjective was to evaluate and compare the in vitro pharmacodynamicsof the clinically available echinocandins in the presence and absenceof these biological matrices against a panel of C. albicans isolateswith reduced echinocandin susceptibility. METHODS: The in vitro pharmacodynamics of caspofungin,micafungin, and anidulafungin were determined against 12 C.albicans clinical isolates, including 11 for which the FKS1 pointmutations were determined. Pharmacodynamic analysis wasperformed using the XTT viability assay at echinocandinconcentrations ranging from 0–32 µg/mL. This was done in duplicatein RPMI, 5% human serum (HS), and 5% bovine serum albumin(BSA) as previously described (Meletiadis et al. J. Clin. Micro.2001;39:3402). IC50 values were calculated by fitting the data to afour-parameter logistic model (Hill equation). RESULTS: The addition of BSA significantly increased the IC50values (mean increase 9-25-fold) of each echinocandin compared toRPMI (p<0.001) and HS (P<0.01). Although the addition of HS didincrease IC50 values compared to RPMI (3–5 fold) the fold-changeswere lower than observed with BSA. The changes in IC50 values wereindependent of the specific FKS1 mutations. The IC50 values for thewild-type isolate (ATCC 90028) did increase with the addition of HSand BSA, but remained < 1 µg/mL for each echinocandin. CONCLUSIONS: The addition of HS and BSA significantlyinfluenced the pharmacodynamics of the echinocandins, but todifferent degrees. Further work is needed to evaluate these matricesfor in vitro pharmacodynamics testing and standardize echinocandintesting in their presence.

145. Simultaneous versus sequential combination therapy withvancomycin plus rifampin for Staphylococcus aureus biofilminfections. Scott J. Bergman, Pharm.D., BCPS1, Jennifer Cho,Pharm.D.2, Vidya Sundareshan, M.D.3; (1)Southern Illinois UniversityEdwardsville, Springfield, IL; (2)Southern Illinois UniversityEdwardsville, Edwardsville, IL; (3)Southern Illinois UniversitySchool of Medicine, Springfield, IL PURPOSE: Staphylococcus aureus is commonly associated withimplant-related infections due to its ability to adhere to medicaldevices and form biofilms. Controversy exists on when to initiatecombination therapy with vancomycin and rifampin. The purpose ofthis study was to determine if the in vitro effects of vancomycin andrifampin on S. aureus biofilms differed when initiated in combinationsimultaneously versus sequentially. METHODS: Thirteen rifampin-susceptible S. aureus isolates frompatients with prosthetic joint infections were grown as biofilms ontransferable solid phase 96-pin lids (Nunc-TSP) incubated overnightrocking in tryptic soy broth with 1% dextrose. Minimum inhibitoryconcentration (MIC) testing was performed by microtiter brothdilution for each drug alone and in a checkerboard combination in thepresence of the pin lid. A fractional inhibitory concentration index(FICI) was calculated for each isolate to determine if combination

therapy provided synergy (≤0.5), indifference (>0.5–≤4), orantagonism (>4). This was compared after two days of exposure tovancomycin plus rifampin, together on each day (simultaneous) orvancomycin alone on day one and then combination therapy on daytwo (sequential).RESULTS: Vancomycin MICs ranged from 2-8 mcg/mL alone whilerifampin MICs were 0.0015–0.0625 µg/mL. Combination therapyresulted in indifference for all isolates when exposed simultaneously(mean FICI=1.24) or sequentially (mean FICI=0.86) except for oneisolate that demonstrated synergy in the sequential arm. CONCLUSION: Most MICs for S. aureus grown in biofilm wereoutside the traditional range of susceptibility when vancomycin wasused alone, but consistently very low for rifampin. No antagonism waspresent in either arm. Although FICI values were lower for thesequential combination, timing of rifampin initiation on day 1 or 2 hadlittle impact on results. Further research will need to be completed todetermine if sequential use of combination therapy is significantlybetter then simultaneous exposure for biofilm infections.

146E. CANVAS 1 and 2: Analysis of clinical response at Day 3from 2 phase III trials of ceftaroline fosamil vs vancomycin plusaztreonam in the treatment of complicated skin and skin structureinfections. Tanya Baculik, M.D.1, Paul B. Eckburg, M.D.1, H. DavidFriedland, M.D.1, Lily Llorens, Ph.D.1, Charles C. Schraa, Pharm.D.2,Alena Jandourek, M.D.1, Gary Witherell, Ph.D.1, Dirk Thye, M.D.1;(1)Cerexa, Inc. (a wholly owned subsidiary of Forest Laboratories,Inc., New York, NY), Oakland, CA; (2)Forest Research Institute,Mechanicsville, VA PURPOSE: There is growing interest in assessment of antimicrobialnoninferiority trials by using different endpoints as predictors ofresponse to provide greater sensitivity to detect possible differencesbetween comparators. Ceftaroline (CPT) fosamil (prodrug of CPT)was previously shown to be efficacious in 2 global, double-blind,randomized trials (CANVAS 1 and 2) that used clinical cure rates atthe test-of-cure visit as the primary endpoint. We conducted asecondary analysis to assess CANVAS 1 and 2 results based onclinical response (CR) at Day 3.METHODS: Hospitalized subjects with complicated skin and skinstructure infections (cSSSI) were randomized to intravenous CPTfosamil 600 mg q12h vs vancomycin/aztreonam (V/A) 1 g/1 g q12hfor 5–14 days. Analyses of CR at Day 3 were conducted in theexploratory modified intent-to-treat (MITT) population, who receivedstudy drug, had lesion size ≥75 cm2, and either an infected surgical ortraumatic wound, major abscess with erythema ≥5 cm, deep/extensivecellulitis, infected arthropod bite, or lower extremity abscess orcellulitis with diabetes mellitus or peripheral vascular disease. CRwas achieved if subjects had cessation of infection spread, wereafebrile at Day 3, and were not considered clinical failures by theinvestigator on Day 3.RESULTS: CR rates at Day 3 were 74.0% (296/400) for CPT fosamiland 66.2% (263/397) for V/A in the combined analysis (exploratoryMITT population; 95% CI: 1.3%, 14.0%). In the individual studies,absolute treatment differences of 9.4% (CANVAS 1) and 5.9%(CANVAS 2) favoring CPT fosamil were observed.CONCLUSIONS: The CR rate from the combined CANVAS trials atDay 3 was higher for patients receiving CPT fosamil versus V/A(lower limit of 95% CI>0). CPT fosamil appears to provide benefitover V/A at Day 3, in terms of cessation of lesion spread andresolution of fever.Presented at Presented at the 31st Annual Meeting of the SurgicalInfection Society, Palm Beach, FL, May 11–14, 2011.

147E. FOCUS 1 and 2: Analysis of clinical response at Day 4 from2 phase III trials of ceftaroline fosamil vs ceftriaxone in thetreatment of community-acquired pneumonia. Paul B. Eckburg,M.D.1, H. David Friedland, M.D.1, Lily Llorens, Ph.D.1, Charles C.Schraa, Pharm.D.2, Alena Jandourek, M.D.1, Gary Witherell, Ph.D.1,Dirk Thye, M.D.1; (1)Cerexa, Inc. (a wholly owned subsidiary ofForest Laboratories, Inc., New York, NY), Oakland, CA; (2)ForestResearch Institute, Mechanicsville, VA PURPOSE: There is growing interest in assessment of antimicrobial METHODS: Hospitalized subjects with moderate-to-severe CAPwere randomized to receive intravenous CPT fosamil 600 mg q12h or

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ceftriaxone (CRO) 1 g q24h for 5–7 daysRESULTS: CR rates at Day 4 were 69.5% (107/154) for CPT fosamiland 59.4% (92/155) for CRO in the combined analysis (exploratory CONCLUSIONS: CR rates (clinical stability + symptomimprovement) from the combined FOCUS trials at Day 4 were higherfor patients receiving CPT fosamil versus those receiving CROCPTappears to provide benefit over CRO at Day 4. Presented at Presented at the 48th Annual Meeting of the InfectiousDiseases Society of America, Vancouver, Canada, October 21–24,2010.

148E. Viridans group streptococci treatment with daptomycin:multinational experience. Kenneth C. Lamp, Pharm.D.1, MinJungYoon, M.P.H.1, Ricardo L. Chaves, M.D., Ph.D.2; (1)CubistPharmaceuticals, Lexington, MA; (2)Novartis Pharma AG, Basel,Switzerland PURPOSE: Viridans group streptococci (VGS) are a common causeof bacteremia and endocarditis. The objective of this study was todescribe the use of daptomycin (DAP) in pts with VGS infections. METHODS: All pts with a culture positive for VGS were studiedfrom the CORE (US, 2005-2009) and EU-CORE (EU and countriesworldwide, 2006-2010) retrospective registries. Investigators assessedoutcome (cure, improved, failure, nonevaluable) at the end of DAPtherapy. RESULTS: Of 9105 pts, 99 (1.1%) pts had VGS infections, 52 (53%)were aged ≥ 51 years and 22% received DAP in an ICU. Underlyingdiseases included cancer (19%) and immunosuppression (10%). Of allpts, 58 (59%) had bacteremia; 23 (23%) pts had endocarditis. DAPwas used as first line therapy in 21 (21%) and 22/78 (28%) of thesecond line use came after prior antibiotic failure. Most frequent priorantibiotics were �-lactams n=52 (53%) or vancomycin/teicoplaninn=35 (35%). Concomitant antibiotics were administered with DAP in66 (67%) pts. The most frequent concomitant antibiotics were beta-lactams, n=44 (44%). The median initial DAP dose was 6 (min 3.3,max 8.3) mg/kg. The median DAP duration was 11 (min 1, max 56)days. Clinical outcomes (success, defined as cured or improved,failed, and nonevaluable) were (78%, 6% and 16%) overall; 81%, 7%and 12% for those (n=58) with positive blood cultures; 83%, 4%, and13% for endocarditis (n=23); and 73%, 3% and 24% for those (n=33)on DAP monotherapy. Two pts had a DAP resistant pathogen (bothfailed); Corynebacterium sp. (DAP MIC > 256 mg/L) and VGS (DAPMIC > 2 mg/L. Adverse events leading to discontinuation werereported in 4% of pts. Serious AEs were reported in 6% of pts. CONCLUSION: The clinical response and safety of DAP weresimilar to other pathogens reported from this registry. These datarequire confirmation via prospective clinical trials. Presented at Presented at the 51st Annual Interscience Conference onAntimicrobial Agents and Chemotherapy, American Society forMicrobiology, Chicago, IL, Sep. 17–20, 2011

149. Characteristics of patients with de-escalated antibiotics basedon culture and sensitivity data: impact on hospital re-admittance.Kimberly Halton, Pharm.D., Jennifer Ng, Pharm.D., BCPS, AnthonyLucchi, Pharm.D., BCPS, Thara Damodaran, M.D.; Mercy GilbertMedical Center, Gilbert, AZ PURPOSE: De-escalation, the concept of targeting antibiotics byusing microbiology results to narrow spectrum or discontinuingantibiotic use, is one way to use antibiotics judiciously. Antibiotic de-escalations have been tracked by Mercy Gilbert Medical Center’sAntimicrobial Stewardship Program since September 2010. Thepurpose of this study was to determine 1) infection markers of patientswith de-escalated antibiotic therapy and 2) the impact of de-escalationon hospital length of stay (LOS) and re-admittance. METHODS: Retrospective review of all patients with a de-escalationrecommendation by a pharmacist from September 2010 to March2011. Patients <18 years old and immunocompromised patients wereexcluded. Data collected include temperature and white blood cellcount (WBC) at time of recommendation, patient demographics,microbiology results, and antibiotic information. RESULTS: One hundred ten patients were identified with an acceptedde-escalation recommendation; 7 of 110 (6%) patients had theirtreatment escalated after de-escalation was made. Sixty-five of 103(63%) recommendations were to discontinue an antibiotic class (e.g.,

Gram-positive). Thirty-nine of 103 (38%) recommendations were tode-escalate therapy. Thirty-seven of 103 (36%) patients had therapychanged with a WBC >10x103/µL. Ten patients of 103 (9%) werefebrile (99–101°F) at time of recommendation; 2 patients had both anelevated WBC and were febrile. The average hospital LOS was 8.6days. Fifteen of 103 (15%) patients were re-admitted within 30 daysfollowing hospital discharge; 3 were re-admitted due to infectiousdisease etiology. Two patients required surgical debridement and onepatient was discharged on an antibiotic resistant to bacteria grown onculture (not recommended by pharmacist). CONCLUSION: The most commonly accepted recommendation wasto discontinue an antibiotic. There did not seem to be a correlationbetween patient outcome and infection markers at time of de-escalation. De-escalation of antibiotics was not associated with anypatients being re-admitted to the hospital.

150. Assessment of antibiogram use in patients with sepsistransferred to a tertiary care facility. Meredith Jernigan, Pharm.D.1,Bonnie A. Falcione, Pharm.D., BCPS2; (1)University of PittsburghMedical Center, Pittsburgh, PA; (2)University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: Sepsis is a life threatening condition associated with highmortality, but the use of appropriate antibiotics early in the treatmentcourse improves survival. Guidelines advocate the use of localantibiograms to select empiric regimens, however, it’s unclear if theseare used in practice, especially when patients are transferred to tertiarycare facilities (TCF). This study evaluated prescriber reportedfrequency and perceived importance of outside hospital (OSH)antibiogram utilization when treating septic patients transferred toTCF. METHODS: The study was conducted with an anonymous electronicsurvey of physicians at seven community and tertiary hospitals withina large health-system. The 25-question survey included Likert-scale,open-ended and multiple-choice formats, and was distributed via anelectronic database three times over four weeks . Respondentdemographics, and reported frequency, perceived importance andbarriers for antibiogram use were collected. Ability to use anantibiogram was also evaluated. Descriptive statistics were used toanalyze demographic data and responses. Comparisons were evaluatedwith c2 or Fisher’s Exact tests. RESULTS: The survey was distributed to 3397 physicians andcompleted by 269 (8%). Of these, 167(62%) reported they care forseptic patients in a TCF and 113 (68%) reported they never use theOSH antibiogram. Use of OSH antibiograms for transferred septicpatients was described as moderately-very important by 135 (80%) ofthese physicians. The most common reported barrier to using OSHantibiograms was information not being available. When tested on theability to use an antibiogram, 214 (80%) used it correctly. CONCLUSION: The majority of surveyed physicians treating septicpatients transferred to TCF perceive antibiogram use as important anddemonstrated correct use. However, most of these physicians neveruse the OSH antibiogram, primarily due to lack of availability. Lack ofantibiogram use may place this group of patients at risk forinappropriate therapy and suggests OSH antibiograms should bereadily available.

151E. Experience with daptomycin for coagulase-negativestaphylococcal bacteremia with elevated vancomycin MICs.Kenneth C. Lamp, Pharm.D., Elizabeth D. Hermsen, Pharm.D.,M.B.A., BCPS, (AQ-ID), Charu Gupta, MSc, MinJung Yoon, M.P.H.;Cubist Pharmaceuticals, Lexington, MA PURPOSE: Coagulase-negative staphylococci (CoNS) are a frequentcause of bacteremia. The purpose of this study is to evaluate DAPoutcomes and safety for treatment of CoNS bacteremia with elevatedvancomycin MICs.METHODS: All pts with CoNS bacteremia were identified in CORE2010, a retrospective, multicenter, observational registry ofstaphylococcal bacteremia pts with VAN MICs ≥ 1.5 mg/L.Investigators assessed pt outcome (cured, improved, failed, NE-nonevaluable) at the end or at last contact during DAP therapy. Theefficacy population was the resulting cured, improved and failed pts.Pt characteristics are based on the efficacy population. All pts wereincluded in the safety analysis.


RESULTS: There were 24 pts evaluable for DAP outcome; median 55yrs; 38% received DAP in an ICU; 13% hemodialysis and 63% hadsevere sepsis. Underlying diseases included diabetes (38%) and cancer(29%). Twelve (50%) pts had catheter-related bacteremia (CRB); 4(17%) pts had endocarditis. DAP median (min, max) initial dose, AR-LOS, and total treatment duration were 6 mg/kg (5, 8.3), 8.5 days (4,31) and 12.5 days (5, 73). Prior antibiotic therapy was utilized in 21pts (88%); most commonly vancomycin (90%). Six (32%) pts failedprior vancomycin therapy. DAP success was documented in 22 pts(92%; cured 58%, improved 33%), 100% (4/4) in endocarditis, 92%(11/12) in CRB and 100% (6/6) in pts who failed prior vancomycin.25 pts were available for safety analysis. Adverse events (AE)occurred in 15 pts (60%); 1 discontinued DAP due to an AE and 4 ptshad AE possibly related to DAP. The all-cause mortality rate to 30days after stopping DAP was 12% (n=3).CONCLUSION: DAP appeared to provide effective and welltolerated therapy for treatment of CoNS bacteremia with elevatedVAN MICs, although these data are non-comparative and include asmall sample size.Presented at Presented at the 51st Annual Interscience Conference onAntimicrobial Agents and Chemotherapy, American Society forMicrobiology, Chicago, IL, Sep. 17–20, 2011

152. Daptomycin use in neutropenic patients with documentedMRSA bacteremia with high vancomycin MICs. John A. Segreti,M.D.1, Dina Besece, Pharm.D.2, Hurdle Anderson, Pharm.D.2, CharuGupta, MSc2; (1)Rush University Medical Center, Chicago, IL;(2)Cubist, Lexington, MA PURPOSE: This report describes utilizing DAP as an alternative toVAN in neutropenic pts with MRSA bacteremia and an elevated VANMIC. METHODS: All pts with neutropenia (≤ 1000 cells/m3) and MRSAbacteremia with VAN MICs of ≥ 1.5 µg/mL were identified in CORE2010, a retrospective, multicenter, observational registry of pts treatedwith DAP. Investigators assessed pt outcome (cured, improved, failed,NE-nonevaluable) at the end or at last contact during DAP therapy. Pt.characteristics are based on the efficacy population. All pts wereincluded in the safety analysis. RESULTS: 10 pts with MRSA bacteremia, neutropenia, and VANMICs ≥ 1.5 µg/mL were identified and evaluable for outcome.Baseline characteristics included: 5 male, 5 ≥ 65 years of age, 3 withinitial CrCl < 30 mL/min (2 on Hemodialysis), and 2 received DAP inan ICU. 6 pts had a history of cancer or transplant. 9 pts had a VANMIC = 2 µg/mL (Vitek ½ N=8, unk N=1) and 1 VAN MIC = 1.5 (E-test). All pts had DAP MIC ≤ 1 µg/mL and all pts received VAN priorto DAP. The median (min,max) duration of VAN therapy was 4.5(1,16) days . The median (min, max) initial DAP dose was 6 mg/kg(5.7,8) The median (min,max) duration of therapy was 15.5 (4,46)days. Success occurred in 80% of pts (3/3 WBC ≤ 100/mm3 and 5/7WBC 101-499/mm3). 1 pt (assessed as DAP failure) was readmittedwithin 60 days of completing DAP therapy for an infection relatedevent. 4 pts experienced a serious AE resulting in 2 deaths, none werepossibly related to DAP. CONCLUSION: DAP was effective and well tolerated in neutropenicpts with MRSA bacteremia and elevated VAN MICs. Further clinicaltrials are warranted.

153E. Improving prescribing and documentation of immunizationand education in patients who undergo emergency splenectomy.Bonnie A. Falcione, Pharm.D., BCPS1, Elisabeth L. George, Ph.D.2,Richard D. Day, Ph.D.3, Susan J. Skledar, B.S., M.P.H.1; (1)Universityof Pittsburgh School of Pharmacy, Department of Pharmacy andTherapeutics; UPMC Presbyterian Hospital, Pittsburgh, PA;(2)University of Pittsburgh School of Nursing, UPMC PresbyterianHospital, Pittsburgh, PA; (3)University of Pittsburgh Graduate Schoolof Public Health, Department of Biostatistics, Pittsburgh, PA PURPOSE: Patients undergoing emergency splenectomy arecandidates for immunization to prevent overwhelming post-splenectomy sepsis. Due to the multiple vaccines needed, and theurgent care setting, the immunization process is error-prone. A qualityimprovement audit at our institution showed errors in vaccineprescribing, dispensing, administration, and documentation. METHODS: After a phased implementation of a customized

physician order set with corresponding dispensing and documentationprocedure, an IRB-approved retrospective review of medical recordsfor patients who underwent an emergent splenectomy between January1, 2008 and December 31, 2009, to evaluate prescribing and requireddocumentation of vaccine administration and patient educationcompared to our historical baseline, was performed. Statisticalanalysis was performed with �2 and Fisher’s Exact tests. RESULTS: We found 76, 110, and 108 patients underwentsplenectomy at our institution in 2007, 2008 and 2009 with 56, 44 and46 evaluable medical records for diagnosis confirmed emergentsplenectomy, respectively. Prescribing and documentation of vaccineadministration for > 1 of the required vaccines increased compared to2007 historical baseline in 2008 after implementing a pre-printedphysician order set (100% vs. 88.6%; p=0.025 and 100% vs. 77.8%;p=0.004, respectively), and in 2009 after implementing acomputerized physician order set (100% vs. 88.6%; p=0.022 and100% vs. 77.8%; p=0.001, respectively). All required elements ofvaccine administration documentation (site, lot number, expirationdate and manufacturer increased between 2007 and 2009 (54.5% vs.97.8%, p<0.001; 31.6% vs. 77.8%, p<0.001; 31.6% vs. 57.8%,p=0.009; 7% vs. 26.7%, p=0.01; respectively). Patient educationdocumentation (not evaluable in 2008) increased in 2009, significantlyduring the six months compared to baseline (17.1% vs. 46.4%;p=0.004). CONCLUSION: These results suggest that implementation of acustomized physician order set (pre-printed or computerized), andcorresponding dispensing and documentation procedure may reduceerrors and omission of required documentation, including education,in patients who undergo emergency splenectomy. Published in Crit Care Med 2010;38(12 Suppl):A1–A306

154. Evaluation of clinical outcomes and adverse events whenadministering alternative doses of linezolid to obese patients.Megan R. Fleming, Pharm.D.1, S. Christian Cheatham, Pharm.D.1,Michael B. Kays, Pharm.D.2; (1)St. Francis Hospitals and HealthCenters, Beech Grove, IN; (2)Purdue University College of Pharmacy,Indianapolis, IN PURPOSE: The WHO recognizes obesity as a global pandemic. Withthe increasing prevalence of obesity, it becomes paramount to exploreoptimal antimicrobial dosing regimens for treating infections in obesepatients. The maximum FDA-approved dose of linezolid is 600 mgIV/PO q12h for adults; however, previous PK/PD analyses suggestlarger linezolid doses may be needed to achieve adequate exposures inobese patients. The purpose of this study was to evaluate clinicaloutcomes and adverse events in obese patients receiving largerlinezolid doses. METHODS: Data were collected by retrospective chart review.Patients included in the analysis weighed > 120 kg and were treatedwith alternative doses of linezolid from January 2004 to December2010. The dosing regimen, duration of therapy, patient outcomes, andadverse events were assessed. Outcome was determined at the end ofhospital stay and defined as cure, improved, or failure. RESULTS: Thirty-five patients received larger doses of linezolid andwere evaluated. Mean ± SD weight and body mass index were 153.7 ±32.5 kg and 51.4 ± 9.4, respectively. The most common linezoliddosing regimen (n=21) was 600 mg IV/PO q8h. Overall, the successrate (cure + improved) was 71.4%. Twenty-three patients (65.7%) didnot experience any documented adverse events on therapy. The mostfrequent adverse event was thrombocytopenia, which developed in 8patients (22.9%). After excluding confounding factors,thrombocytopenia developed in 3 patients (8.6%). The onset ofthrombocytopenia in these two groups was 6.7 days and 9 days,respectively. The overall duration of therapy was 7.7 ± 4.9 days. CONCLUSIONS: Similar clinical outcomes were observed in thisobese population as previously reported in clinical trials withlinezolid. These findings may suggest that empiric dose optimizationis needed when treating obese patients with linezolid. Increasedincidence of thrombocytopenia may be related to severity of illnessand/or other confounding factors.

155. Tigecycline use and selection of Pseudomonas aeruginosa.Scott J. Bergman, Pharm.D., BCPS1, Bart A. Smith, Pharm.D.2, VidyaSundareshan, M.D.3, Janak Koirala, M.D.3; (1)Southern Illinois

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University Edwardsville, Springfield, IL; (2)Southern IllinoisUniversity Edwardsville, Benton, IL; (3)Southern Illinois UniversitySchool of Medicine, Springfield, IL PURPOSE: Tigecycline is one of the broadest spectrum antibacterialagents available, but it does not have activity against Pseudomonasaeruginosa. The purpose of this study was to determine if patientsbeing treated with tigecycline grew P. aeruginosa from their culturesmore often than those being treated with tigecycline plus anantipseudomonal antibiotic. METHODS: Patients were included if they received tigecycline for >48 hours while hospitalized anytime during 2009. Patients wereexcluded if cultures grew P. aeruginosa prior to tigecycline initiationduring that admission or in the first 48 hours of therapy. Includedpatients were split into two arms: those that received concurrentantipseudomonal antibiotics (i.e., aminoglycosides, aztreonam, certainb-lactams & fluoroquinolones) while on tigecycline and those that didnot. Patients were counted as positive if they grew P. aeruginosa ontherapy or within 10 days after discontinuation. RESULTS: Charts were reviewed for all 260 patients receivingtigecycline and data collected for those 194 meeting inclusion criteria.A majority were excluded for not being on tigecycline the required 48hours. Of the 85 patients receiving tigecycline without concurrentantipseudomonal therapy, seven (8.24%) had positive cultures for P.aeruginosa compared to nine out of 109 (8.26%) patients on tigecylineplus antipseudomonal therapy. Sites of positive cultures were similarin both groups (tigecycline, combination) and included urine (3,3),wound (3,3) sputum (1,3), bone (0,2) and catheter (2,0). Patients withdiabetes were more likely to be treated with antipseudomonalantibiotics (24.7% vs. 45.8%, p<0.05), but were also more likely todevelop positive cultures compared to non-diabetics (2.4% vs 18.3%,p<0.05). CONCLUSION: Patients treated with tigecycline were no morelikely to grow P. aeruginosa than patients on combination therapywith an antipseudomonal antibiotic. Patients with diabetes may stillneed to receive antipseudomonal antibiotics along with tigecyclinebecause of their high-risk of P. aeruginosa.

156. Empiric anti-MRSA antibiotics for MRSA pneumonia in acommunity hospital. Paul Juang, Pharm.D., Jennifer S. Hardesty,Pharm.D.; St. Louis College of Pharmacy, St. Louis, MO PURPOSE: With recent increases in the rates of methicillin-resistantStaphylococcus aureus (MRSA) pneumonia, multiple groups haverecommended the addition of anti-MRSA antibiotics in the empirictreatment of suspected pneumonia in patients with MRSA risk factorsdue to the clinical implications associated with inadequate initialempiric therapy. The purpose of this study is to examine theappropriate empiric treatment of MRSA pneumonia and the rate ofmodification of antibiotic therapy. METHODS: A retrospective data analysis was conducted using anelectronic data repository to identify patients 18 years of age or olderwith ICD-9 codes for pneumonia. Pregnant patients, patients withhospital-acquired or ventilator-associated pneumonia and patients notstarted on antibiotics within 24 hours of admission were excluded. Theprimary results were the rate of appropriate empiric anti-MRSAantibiotic usage in patients with culture-positive MRSA pneumoniaand the rate of de-escalation based on available microbiologicalresults. Secondary results included length of antibiotic usage, length ofhospital stay and discharge disposition. Descriptive statistics wereutilized where appropriate. RESULTS: From January 1 to December 31, 2010, 2521 patientswere admitted with suspected pneumonia, of which 423 patientsreceived vancomycin while only 29 patients had positive sputumcultures for MRSA. In patients with positive MRSA sputum cultures,24 patients were identified as having healthcare-associated pneumoniaand 5 patients with community-acquired pneumonia with 20 patientsstarted on appropriate anti-MRSA regimen empirically. Only 6/29patients had their antibiotic regimen deescalated based on cultureresults. The average length of stay was 10 ± 7 days and 18/29 of thepatients were discharged to home. CONCLUSION: Our study suggests a need for a different approachto adhering to guidelines for empiric coverage in patients admitted forMRSA pneumonia. These results have encouraged the institution torevise the pneumonia order set and examine the utilization of anti-

MRSA antibiotics.

157. Analysis of outcomes and risk factors associated withextended-spectrum b-lactamase-production in bloodstreaminfections. S. Travis King, Pharm.D., Laleh Azari, Pharm.D., JenniferD. Twilla, Pharm.D., BCPS, Justin B. Usery, Pharm.D., BCPS;Methodist University Hospital, Memphis, TN PURPOSE: Infections with multidrug-resistant Enterobacteriaceaeare increasing. A major mechanism of resistance within this family isproduction of extended-spectrum b-lactamases (ESbLs), which conferresistance to cephalosporins, penicillins, and monobactams. Our studysought to determine the clinical and microbiologic outcomes and riskfactors associated with ESbL(+) infections. METHODS: We conducted a retrospective analysis of patients withKlebsiella pneumoniae, K. oxytoca, or Escherichia coli bacteremia.Cultures were identified using a microbiology laboratory report andstratified based on ESbL production. All ESbL(+) organisms werescreened for inclusion. Three non-ESbL isolates were randomlyselected for each ESbL(+) isolate. Included patients were at least 18years of age with 1 or more positive blood culture(s); polymicrobialcultures and patients with less than 48 hours of data were excluded. RESULTS: Eighty-eight patients were included (22 ESbL and 66non-ESbL). Demographics were similar between groups. Clinical cure(59.1 vs. 65.2%, p=0.6), microbiologic cure (100 vs. 91.8%, p=0.5),and mortality (22.7 vs. 18.2%, p=0.7) did not differ between ESβL(+)and non-ESβL groups, respectively. Presence of an ESbL(+) infectionwas associated with a longer length of stay, presence of an invasivedevice at admission, antibiotic exposure in the prior 30 days, andhospitalization in the prior 90 days (p<0.05 for all). Patients withESbL(+) strains were more likely to receive inadequate initialantimicrobial therapy (27.3 vs. 4.6%, p<0.007). Of ESβL(+) patientstreated with piperacillin/tazobactam (n =8), 75% achieved clinicalcure and 100% of those with repeat cultures (n=6) achievedmicrobiologic cure. CONCLUSION: ESbL status did not significantly affect rates ofclinical or microbiologic cure or mortality. Significantly more patientswith ESβL(+) infections were inadequately treated empirically.ESbL(+) infections were associated with risk factors indicative ofprior healthcare exposure. Results of this study should be interpretedcarefully given the limited sample size and should be assessed inprospective studies.

158. Pharmacokinetics and pharmacodynamics of meropenem inmorbidly obese, hospitalized patients. S. Christian Cheatham,Pharm.D.1, Megan R. Fleming, Pharm.D.1, Daniel P. Healy, Pharm.D.2,Christina E. K. Chung, Pharm.D.3, Michael B. Kays, Pharm.D.3; (1)St.Francis Hospitals and Health Centers, Beech Grove, IN; (2)JamesWinkle College of Pharmacy, University of Cincinnati, Cincinnati,OH; (3)Purdue University College of Pharmacy, Indianapolis, IN PURPOSE: Obesity is a major healthcare crisis worldwide, but onlylimited data are available regarding antimicrobial pharmacokineticsand appropriate dosing in morbid obesity. The purpose of this studywas to evaluate the steady-state pharmacokinetics andpharmacodynamics of meropenem in patients who are morbidly obese. METHODS: Hospitalized patients with a BMI > 40 kg/m2 wereenrolled. Patients received meropenem 1000 mg q6h (n=8) or 500 mgq6h (n=2), infused over 30 minutes. Serial blood samples werecollected at steady-state, and meropenem concentrations weredetermined by HPLC. Meropenem PK parameters were estimated by RESULTS: Four men and 6 women were studied. Patientdemographics were (mean ± SD): age 56 ± 10 years; weight 163 ± 22kg; BMI 60.6 ± 8.2 kg/m2, creatinine clearance 73 ± 26 ml/minute.Mean ± SD elimination rate, half-life, bCONCLUSIONS: Despite changes in b

159. Pharmacokinetic and safety analysis of high-dosemoxifloxacin in a morbidly obese individual. S. Travis King,Pharm.D.1, Ngan H. Vo, Pharm.D., BCPS1, Andrew C. Faust,Pharm.D., BCPS1, Dipen Kadaria, M.D.2, John W. Thompson, M.D.2,Matthew W. Mabie, M.D.3; (1)Methodist University Hospital,Memphis, TN; (2)University of Tennessee Health Science Center,Memphis, TN; (3)Mid-South Pulmonary Specialists, Memphis, TN


PURPOSE: Antimicrobial dosing in the obese population remainsimprecise. A 340 kg female with past medical history of chronicobstructive pulmonary disease and penicillin allergy presented to ourinstitution in respiratory distress. Within 24 hours of intubation, shedeveloped a pulmonary infiltrate and was initiated on antibiotictherapy with moxifloxacin 400 mg IV daily plus vancomycin 1 gramIV every 6 hours for suspected community-acquired pneumonia;moxifloxacin was increased to 800 mg IV daily after 48 hours oftherapy. Herein, we present the results of a pharmacokinetic and safetyanalysis of high-dose intravenous (IV) moxifloxacin in this morbidlyobese individual. METHODS: Baseline and serial electrocardiogram (EKG), liverfunction tests, blood glucose measurements, and neurologicassessments were ordered to assess safety. Five moxifloxacin serumconcentrations were measured following the third dose of 800 mg athours 3, 7, 11, 19, and 24. Area under the concentration-time curve(AUC) was calculated using Simpson’s rule. A deep tracheal aspiratewas obtained for microbial identification. RESULTS: Pharmacokinetic assessment revealed a moxifloxacinAUC of 38.05 mg•h/L, CL of 9.9 L/hr, half-life of 17.3 hrs, and Vd of0.7 L/kg. This is comparable to a steady-state AUC of 38 +/- 4.7mg•h/L following multiple daily doses of moxifloxacin 400 mg IV inhealthy adults. No changes were seen in the corrected QT interval.AST and ALT remained within normal range. Blood glucoses rangedfrom 124–183 mg/dL, with no increases in insulin requirements. Thepatient’s neurologic status remained stable, with no evidence ofseizure activity. Culture results demonstrated 2+ Streptococcuspneumoniae with a moxifloxacin MIC = 3 (via E-test). CONCLUSION: Moxifloxacin 800 mg IV daily appears safe andachieved an AUC comparable to those achieved in healthy patientsreceiving standard dose therapy. AUC/MIC assessment in this patientis limited due to moxifloxacin resistance.

160. Efficacy and safety of six months of low- vs. high-dosevalganciclovir for prevention of Cytomegalovirus disease in high-risk renal transplant recipients. Steven Gabardi, Pharm.D., BCPS1,Lisa M. McDevitt, Pharm.D., BCPS2, Christin Rogers, Pharm.D.3, EricTichy, Pharm.D., BCPS4, Renee Weng, Pharm.D.5, Ruth-Ann M. Lee,Pharm.D.6; (1)Department of Pharmacy & Renal Divison, Brigham &Women’s Hospital; Department of Medicine, Harvard Medical School,Boston, MA; (2)Tufts Medical Center, Boston, MA; (3)Beth IsraelDeaconess Medical Center, Boston, MA; (4)Yale-New HavenHospital, New Haven, CT; (5)UC-Irvine, Orange, CA;(6)Massachusetts General Hospital, Boston, MA PURPOSE: Prolonged (200 days) cytomegalovirus (CMV)prophylaxis using valganciclovir (VGC) 900 mg/day has provenefficacy, yet some centers continue to utilize 450 mg/day due to itsreported success and potential cost savings. This study compared theefficacy and safety of 6 months of low-dose vs high-dose VGCprophylaxis in high-risk renal transplant recipients (RTR). METHODS: A multicenter, retrospective analysis evaluated 183 adultRTR between 8/1/2001 and 12/31/2009. Group 1 (n=106) receivedVGC 450 mg/day and Group 2 (n=77) received VGC 900 mg/day.VGC was started post-operatively and dose adjusted for renal functionwith goal duration of 6 months. The primary endpoint was CMVdisease prevalence at 1 year. The rates of breakthrough CMV, resistantCMV, AR, graft loss, opportunistic infections (OI), new-onset diabetesafter transplant (NODAT) and early VGC discontinuation (DC), aswell as, renal function (RF) and hematologic lab values were alsoevaluated. RESULTS: Patient demographics and transplant characteristics werecomparable. All patients received antithymocyte globulin inductiontherapy and maintenance immunosuppression was similar throughoutthe study, with the exception of complete steroid withdrawal occurringmore in Group 2 (37.7% vs 74%; p<0.0001).

12 Month Efficacy Analysis Group 1 Group 2 P-value CMV disease 16 (15.1%) 21 (27.3%) 0.061 - Breakthrough Disease 3 (18.8%) 3 (14.3%) 1.000 - Resistant Disease 0 (0%) 4 (19%) 0.118 AR 16 (15.1%) 10 (13%) 0.831 RF (ml/min/1.73m2) 46.4 + 18.1 45.4 + 15.5 0.696 Graft Loss 1 (0.9%) 2 (2.6%) 0.574

OI 23 (21.7%) 12 (15.6%) 0.345 NODAT 9 (8.5%) 2 (2.6%) 0.123The safety analysis showed similar results. The rate of early VGC DCdue to myelosuppression was similar in each group. CONCLUSION: Both regimens provide similar efficacy inprevention of CMV disease in high-risk RTR. The need for early VGCDC secondary to hematologic adverse events was comparable.

161. Effect of implementing an electronic order menu fortrimethoprim-sulfamethoxazole on changing prescriber orderingbehavior and decreasing adverse events in elderly outpatientveterans. Tina M. Khadem, Pharm.D, Kimberly MacKay, Pharm.D,Ronald Brown, R.Ph; Portland VA Medical Center, Portland, OR PURPOSE: In September of 2009, the Portland VA Medical Centerimplemented an electronic order menu for trimethoprim-sulfamethoxazole (TMP-SMX). This retrospective chart reviewexamined the effect of this on prescriber ordering behavior bycomparing the change in the percentage of patients prescribed therapyin the presence of contraindications, precautions, and missing labvalues. Additionally, this study evaluated the change in the number ofadverse events. METHODS: Medical records of 248 veterans who receivedoutpatient prescriptions for at least 5 days of therapy betweenSeptember 1, 2008 to August 31, 2008 and January 1, 2010 toDecember 31, 2010 were reviewed. Patient demographics, laboratorydata, concomitant medications, comorbidities, TMP-SMX data,adverse events and hospitalizations for hyperkalemia and acute renalinsufficiency were documented. RESULTS: Before the order menu was implemented, two patientswere prescribed TMP-SMX in the presence of contraindications whilenone were prescribed the drug after order menu implementation (1.6%vs. 0.0%, p=0.471). The percentage of patients prescribed therapy inthe presence of 3 or 4 precautions also decreased (11.4% vs. 10.4%and 2.4% vs. 1.6% respectively, p=0.714). The percentage of patientsprescribed therapy in the presence of 2 precautions and in the presenceof missing lab values increased (45.5% vs. 48.8%, p=0.814; 11.4% vs.17.6%, p=0.226). A greater proportion of patients experienced adverseevents before the order menu was implemented. In the patients whoreceived TMP-SMX before order menu implementation, baselineaverage serum creatinine was higher and the estimated glomerularfiltration rate was lower (1.2 mg/dL vs. 1.0 mg/dL, p=0.012; and 73ml/min vs. 82 ml/min, p=0.002). CONCLUSIONS: Implementation of the TMP-SMX electronic ordermenu did not significantly change prescriber ordering behavior.However, a beneficial effect of the order menu may be seen whencomparing baseline average serum creatinine and estimatedglomerular filtration rates before and after the order menu.

162. Evaluation of colistimethate use in the Shock Trauma Centerat the University of Maryland Medical Center. Jennifer L. Bailey,Pharm.D., Mehrnaz Pajoumand, Pharm.D., Sai-Ho Jason Chui,Pharm.D., Ellis Caplan, M.D.; University of Maryland MedicalCenter, Baltimore, MD PURPOSE: Colistimethate (CMS) has recently become the preferredformulary polymyxin at the University of Maryland Medical Center;however, concerns with dosing inconsistency and failure to utilizeideal body weight (IBW) as well as nephrotoxicity risk exist. Giventhe limited preexisting literature in trauma patients, a medicationutilization evaluation was performed to 1) describe the prescribingtrends of CMS and 2) assess the incidence of CMS nephrotoxicity atthe Shock Trauma Center (STC). METHODS: A retrospective chart review was performed on patients(N=46) admitted to the STC who received ≥ 1 dose of CMS between2008 and 2010. Renal function, dosing regimen, previous andconcomitant nephrotoxic agent administration, nephrotoxicity (usingRIFLE criteria), and need for new renal replacement therapy (RRT)was collected. Descriptive statistics were performed as appropriate. RESULTS: Nine patients received multiple CMS courses, resulting in57 courses analyzed. The mean daily dose (using IBW) prescribed was4.3 mg/kg/day, (range 0.9–9 mg/kg/day) and a mean of 9 days oftherapy was received. Eighteen patients required RRT at baseline. Ofthe remaining population, 16 patients (57%) met nephrotoxicitycriteria (R=5 patients, I=7 patients, F=4 patients); however, 15

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received additional nephrotoxic agents and 7 had baseline SCr levels≤0.5 mg/dL. Of 8 patients who required new RRT, 7 recovered renalfunction by discharge and 1 patient expired. CONCLUSIONS: A wide range of CMS dosing was observed,creating potential for under- and overdosing and serves as an area forfuture pharmacist intervention. While nephrotoxicity criteria were metin over one-half of eligible patients, there was not a need for RRTbeyond hospitalization in this population.

163E. Isoniazid blood levels in patients with pulmonarytuberculosis at a tuberculosis referral center. Fanak Fahimi,Pharm.D.1, Shadi Baniasadi, Pharm.D., Ph.D.2, Farzad Kobarfard,Pharm.D., Ph.D.3, Payam Tabarsi, M.D.4, Shabnam Hemmati,Pharm.D.5, Jamshid Salamzadeh, Pharm.D., Ph.D.6; (1)PharmaceuticalCare Department, Chronic Respiratory Disease Research Center,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti, Tehran, Iran;(2)Pharmaceutical Care Department, Virology Research Center,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University.,Tehran, Iran; (3)Medicinal Chemistry Department, School ofPharmacy, Shahid Beheshti University. M.C., Tehran, Iran, Tehran,Iran; (4)Chronic Respiratory Disease Research Center, NRITLD,Masih Daneshvari Hospital, Shahid Beheshti University. M.C.,Tehran, Iran; (5)Clinical Pharmacy Department, School of Pharmacy,Shahid Beheshti University. M.C., Tehran, Iran; (6)Clinical PharmacyDepartment, School of Pharmacy, Shahid Beheshti University ofMedical Sciences Tehran, Tehran, Iran PURPOSE: To evaluate the serum concentration of isoniazid (INH)in Iranian patients and to determine the factors correlated to theplasma INH level. METHODS: Blood samples were obtained 2 hours post ingestion of5 mg/kg INH in 82 patients (one sample per patient) who were in days3–15 of treatment. Investigated variables were INH plasma level,duration of therapy, age, sex, weight, dose of administered drug, andsmoking status. RESULTS: The average±SD age and weight of patients were 60.68 ±18.53 years and 74.96 ± 7.15 kg respectively. Prevalence of low andhigh concentration of INH was 14.63% and 23.17% respectivelywhere reference ranges was 3-5 mcg/ml. Days of INH administrationshowed statistical correlation with plasma INH level (Kendall’s rankcorrelation, r=0.66, p <0.001). INH plasma level was not correlatedwith other variables. CONCLUSION: Based on the result of this study plasmaconcentrations of INH were not in therapeutic ranges for 37.80% ofpatients on conventional therapy. Therapeutic drug monitoring (TDM)may be needed to optimize INH dose, especially in patients withinadequate clinical response or toxicity to INH. Key words: Bloodlevel, Isoniazid, Tuberculosis, Monitoring Published in Published in Chemotherapy 2011;57:7–11

Managed Care

164E. The first pharmacist based warfarin monitoring service inIran. Fanak Fahimi, Pharm.D.1, Shadi Baniasadi, Pharm.D., Ph.D.2,Babak Sharif-Kashani, M.D.3, Zargham Hossein Ahmadi, M.D.4,Jamshid Salamzadeh, Pharm.D., Ph.D.5, Rocsanna Namdar,Pharm.D.6, Sara Mousavi, Pharm.D., Ph.D.7, Shadi Ziaie, Pharm.D.,Ph.D.5, Leila Ghazi –Tabatabei, Pharm.D.8, Golnar Radmand, M.S.9,Mohammad Reza Masjedi, M.D.10; (1)Pharmaceutical CareDepartment, Chronic Respiratory Disease Research Center, NRITLD,Masih Daneshvari Hospital, Shahid Beheshti, Tehran, Iran;(2)Pharmaceutical Care Department, Virology Research Center,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University.,Tehran, Iran; (3)Tobacco Prevention and Control Research Center,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University ofMedical Scie, Tehran, Iran; (4)Lung Transplantation Research Center,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University ofMedical Sciences, Tehr, Tehran, Iran; (5)Clinical PharmacyDepartment, School of Pharmacy, Shahid Beheshti University, M.C.,Tehran, Iran; (6)University of Colorado Anschutz Medical Campus,Aurora, CO; (7)Clinical Pharmacy Department, School of Pharmacy,Tehran University of Medical Science, Tehran, Iran;(8)Pharmaceutical Care Department, Chronic Respiratory DiseaseResearch Center, NRITLD, Masih Daneshvari Hospital, Shahid

Behesh, Tehran, Iran; (9)Epidemiology and Biostatistics Center ,NRITLD, Masih Daneshvari Hospital, Shahid Beheshti University ofMedical Sciences,Te, Tehran, Iran; (10)Chronic Respiratory DiseaseResearch Center, NRITLD, Masih Daneshvari Hospital, ShahidBeheshti University of Medical Sciences, Tehran, Iran PURPOSE: This paper evaluates the adequacy of anticoagulationcare and determines the effects of consultation services in the firstpharmacist-based anticoagulation clinic in Iran. METHODS: The anticoagulation clinic of Masih DaneshvariHospital was established by a clinical pharmacist. In a prospectivecohort study, all patients on warfarin therapy who were referred to thisclinic were followed during a 4 month period. Patients were monitoredand consulted based on a predetermined guideline. The primarydesired outcome was the control of INR per therapeutic range. Datawas gathered on the indication of warfarin therapy, the pharmacist’sinterventions, and the adverse drug effects experienced by theparticipants. Descriptive statistics and logistic regression model wereused to present the results. RESULTS: A total of 76 patients were included out of which 42.1%were male. The mean age (±SD) of the participants was 50 (±17). Themain indications for warfarin prescription were treatment of DeepVein Thrombosis or Pulmonary Emboli (46.1%) and Mechanical ValveReplacement (23.7%). The primary reason for referral of patients tothe clinic was routine monitoring (32.9%) and INR control (31.3%).The most common intervention by the pharmacist was increasing thedose (31.6%). Of the referred patients, 47.7% reached the target INRon follow up visits while the INR in 11.8% of them was not within thedesired range. None of the clinical interventions performed by theresponsible physicians for the management of bleeding wascompatible with our guidelines. There was a trend between the properuse of warfarin and reaching the target goal of the INR (OR: 2.97, P:0.09) CONCLUSION: The results demonstrate that an anticoagulationclinic managed by a clinical pharmacist offers not only a safe andeffective treatment but also a better care with respect toanticoagulation control. Published in Journal of Pharmaceutical Health Services Research2011;2:59–62

Medication Safety

165. Implementation of medication reconciliation by a pharmacistin patients with human immunodeficiency virus or acquiredimmune deficiency syndrome on highly active antiretroviraltherapy. Courtney L. Tam, Pharm.D.1, Tomasz Z. Jodlowski,Pharm.D., BCPS, (AQ-ID)2; (1)Beth Israel Medical Center - PetrieCampus, New York, NY; (2)St. John’s University College ofPharmacy and Allied Health Professions, Queens, NY PURPOSE: Obtaining accurate and complete medication historyremains a problem at many hospitals. Following the JointCommission’s National Patient Safety Goals, this qualityimprovement project (QIP) evaluated the effectiveness of medicationreconciliation conducted by a pharmacist, in patients with humanimmunodeficiency virus (HIV) or acquired immune deficiencysyndrome (AIDS) on Highly Active Antiretroviral Therapy (HAART),a high risk group for medication errors. METHODS: This was a prospective QIP that took place betweenDecember 2010 and February 2011; IRB exemption was obtained. Alist of patients with HIV on HAART was accessed and eligiblepatients identified using predetermined inclusion/exclusion criteria. Apharmacist performed medication reconciliation within forty eighthours of admission using the following methods and compared theresults to the current standard (current medication reconciliationprocess by a physician or nurse). Medication reconciliation includedthe use of a structured patient questionnaire, review of documents inthe chart, and contact with an outpatient pharmacy and/or primary careprovider. Discrepancies were communicated to the primary team forimplementation when appropriate. RESULTS: A total of 18 patients were included in this QIP; mostlyfrom the medicine units. The medication history was completed by apharmacist in approximately 30 minutes. The pharmacist identifiedmore medications than the current standard (16.4 versus 10.7, p<0.05). Interventions were suggested (89%; 16 out of 18 patients) to


the primary team and most were accepted (78%; 34 out of 43interventions). There were discrepancies in HAART or opportunisticinfection regimens (42%; 18 out of 43 interventions) and other diseasestate medications (58%; 25 out of 43 interventions).CONCLUSION: Obvious differences were identified between themediation reconciliation performed by a pharmacist versus the currentstandard. This project demonstrates a potential benefit in the use ofpharmacists, medication experts, in obtaining more completemedication reconciliation in patients with HIV/AIDS on HAART.

166. Apixaban and rivaroxaban safety after hip and kneearthroplasty: a meta-analysis. Carlos Alves, Pharm.D.1, Ana F.Macedo, Pharm.D., Ph.D.2, Francisco Batel-Marques, Pharm.D.,Ph.D.3; (1)CICS – Health Sciences Research Centre, University ofBeira Interior; School of Pharmacy, University of Coimbra, Coimbra,Portugal; (2)Central Portugal Regional Pharmacovigilance Unit -AIBILI; CICS - Health Sciences Research Centre, University of BeiraInterior, Covilhã, Portugal; (3)Central Portugal RegionalPharmacovigilance Unit - AIBILI; School of Pharmacy, University ofCoimbra, Coimbra, Portugal PURPOSE: Safety of Xa coagulation factor direct inhibitors holdinga European market authorization, apixaban and rivaroxaban, havenever been evaluated by direct comparisons in randomized controlledtrials. Approved therapeutic indications for both drugs arethromboprophylaxis after hip or knee arthroplasty. This study aims atevaluating available published data to further compare drugs safetyprofiles. METHODS: A meta-analysis was carried out pooling data fromstudies identified on a Medline and Cochrane Library search.Abstracts from scientific meetings were also searched from 2003 to2011. Primary and secondary outcome measures were major bleedingand total bleeding, respectively. Relative risks (RR) were estimatedusing random-effects models and statistical heterogeneity wasestimated with I2 statistics. RESULTS: Of the 160 screened publications twelve clinical trialswere included in which enoxaparin was the active control. For kneearthroplasty, apixaban was associated with significantly fewer majorbleeding events (6496 patients, RR 0.56, 95% CI 0.32–0.96) andfewer total bleeding events (6496 patients, RR 0.81, 95% CI0.67–0.97). There were no significant differences in the incidence ofmajor bleeding events (5699 patients, RR 1.40, 95% CI 0.56–3.52) orin the incidence of total bleeding events for rivaroxaban (5699patients, RR 1.09, 95% CI 0.91–1.30). No differences were foundwhen thromboprophylaxis after hip replacement was the case. CONCLUSION: Apixaban compared to rivaroxaban seems to beassociated with a lower risk of the incidence of hemorrhagic eventsafter total knee arthroplasty. For hip arthroplasty no safety differenceswere found.

167. The role of computerized clinical decision support inreducing Inappropriate medication administration duringepidural therapy. Jonathon Pouliot, M.S., Pharm.D., Erin Neal,Pharm.D., BCPS; Vanderbilt University Medical Center, Nashville,TN PURPOSE: Continuous epidural anesthesia therapy is commonlyused for pain management, particularly during the peri-operative andpost-operative periods. Epidural administration of drugs puts patientsat risk for complications, the most serious being bleedingcomplications which could cause irreversible neurologic damage. Amajor risk factor for complications is administration ofcontraindicated or high risk anticoagulants, antiplatelets,thrombolytics, and sedative medications. In order to decrease theadministration of contraindicated and inappropriate medications andstandardize epidural ordering facility-wide, an electronic epiduralordering advisor has been implemented into the computerizedphysician order entry (CPOE) system at Vanderbilt University MedicalCenter. The purpose of this study is to evaluate the effectiveness ofthis advisor at reducing occurrences of inappropriate medicationadministration as well as reducing complications of therapy. METHODS: This study examined the incidence of high riskmedication administration before and after CPOE advisorimplementation in 404 adult patients receiving epidural anesthesiatherapy between July 2010 and January 2011. This study also

evaluated some common adverse events and complications of epiduraltherapy before and after intervention. RESULTS: In the period prior to implementation, inappropriatemedications were administered in 12.8% of cases compared to 11.4%of cases after advisor implementation (p=0.67.) Promethazine andenoxaparin were the most commonly administered inappropriatemedications. There were no statistically significant differencesbetween groups for complications including hypotensive events,respiratory depression, naloxone administration or rapidresponses/codes. CONCLUSION: Based on the results of this study, theimplementation of an epidural ordering advisor did not result in fewerinappropriate medications administered to patients receiving epiduraltherapy. It is possible that the functionality of this advisor interventionwas not optimized and could have resulted in lack of effectiveness.The results of this study emphasize the importance of properutilization of our informatics and technology tools in order to bestimpact patient safety and care.

168. Compliance with NASPE monitoring guidelines foramiodarone. Prudence Hofmann, Pharm.D.1, Ola O. Oyetayo,Pharm.D.2, Carrie Rogers, Pharm.D.1, Phillip Lubanski, Pharm.D.1,Cheryl Holt, Pharm.D.1, Tera Moore, Pharm.D.1; (1)South TexasVeterans Health Care System, San Antonio, TX; (2)Univeristy ofTexas at Austin/ Univeristy of Texas Health Science Center at SanAntonio, San Antonio, TX PURPOSE: To determine the rates of compliance with NorthAmerican Society of Pacing and Electrophysiology (NASPE)recommended monitoring for patients receiving chronic amiodaronetherapy at the South Texas Veterans Health Care System (STVHCS).Given the potential adverse effects of amiodarone, a strict monitoringregimen is essential to the safe use of amiodarone. METHODS: Retrospective chart review of patients receivingamiodarone for > 6 months at STVHCS between January 1, 2002 andMarch 31, 2010. Compliance with NASPE monitoring guidelineswere recorded at baseline, 6 months, and 12 months for the followingparameters: chest radiography (CXR), pulmonary function test (PFT)with DLCO, liver function test (LFT), thyroid function test (TFT),electrocardiogram (ECG) and eye exam. RESULTS: A random sample of 251 patients was selected out of 827patients who met the inclusion criteria. Compliance rates in patientsvaried according to test. At baseline, it ranged from 6% for a DLCOtest to 63% for a LFT test (CXR – 29%, PFT – 7%, TFT – 35%, ECG– 36% and eye exam- 10%). At 6 months, recommended TFT and LFTmonitoring were completed in 26% and 49% of patients respectively.At 12 months, compliance rates for CXR, TFT, LFT and ECGmonitoring were 12%, 30%, 53% and 15% respectively. The rate ofcompliance was greater at baseline in patients initiated at STVHCScompared to an outside facility. CXR was completed in 80% vs. 13%,PFT 25% vs. 1%, TFT 53% vs. 30%; LFT 90% vs. 54%; and ECG85% vs. 20% (all comparisons p<0.001). Comparisons at 6 monthsand 12 months remained statistically significant for all parameters. CONCLUSION: Overall compliance with NASPE monitoringparameters for amiodarone was suboptimal. There is a need to provideadditional education and perhaps a clinical reminder within theelectronic medical record to ensure the safe use of amiodaronetherapy.

169. Medication reconciliation: comparing a customizedmedication history form to a standard medication form. (CAMPII2 ). Gina J. Ryan, Pharm.D.1, Jane M. Caudle, MLn2, Mary Rhee,M.D.2, Jamye M. Hickman, Ph.D.3, Circe W. Tsui, M.S.2, Catherine SBarnes, Ph.D.2, Jia Haomia, Ph.D.4, David C Ziemer, M.D., M.P.H.2;(1)Mercer University College of Pharmacy and Health Sciences,Atlanta, GA; (2)Emory University School of Medicine, Atlanta, GA;(3)Southern Polytechnic State University, Marietta, GA; (4)ColumbiaSchool of Nursing, New York, NY PURPOSE: Investigators compared the accuracy of an APhA fill-in-the-blank medication history form (STANDARD) to a customizedform (CUSTOM) that contained a checklist of the clinic’s mostfrequently prescribed medications (CORE) and a fill-in-the-blanksection for those medications not on the checklist. METHODS: CUSTOM was designed by a diabetes clinic

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committee: endocrinologists, clinical pharmacist, certified diabeteseducator, human factor engineer, and program manager. The contentof both forms was compared to a “gold standard” medication listcompiled by a clinical pharmacist using a thorough medication history,reviews of the pharmacy profiles and medical charts. Accuracy wasdefined as complete (name, dose, and frequency) and correct relativeto the gold standard. RESULTS: Diabetic subjects (N=77) completed CUSTOM andSTANDARD; 52 (68%) were female, average age was 55.4 ± 11.6,and took 8.6 ± 3.3 number of medications. When looking at allmedications, having a list or medications bottles improved recall withSTANDARD (P=0.03) in a regression analysis. Age decreasedaccuracy when looking at only CORE medications with both forms(P<0.03).

CUSTOM STANDARD Minutes to Complete 8.9 ±5.9 8.0 ±5.5 Subjects N(%) with: All Meds Completely Accurate 5 (6.4%) 8 (10.4%) Subjects with All Names Accurate 16 (20.8%) 10 (13.0%) Extra Drug Names 10(13.0%) 5 (6.4%) CORE Meds* 18 (23.4%) 15 (19.4%) Preferred By** 66% 33%

*P=0.0043 Adjusted for number of medications. **P<0.007 CONCLUSION: Medication self-report is very poor. However, acustomized list improves accuracy by about 20%. Subjects preferredCUSTOM over STANDARD. Clinics considering using a customizedchecklist to collect medication histories from patients should knowthat it provides modest benefits for the medications on the checklist.

170. Medication errors reported by US clinical pharmacists: theACCP PBRN MEDAP study. Grace M. Kuo, Pharm.D., M.P.H.,Ph.D.1, Daniel Touchette, Pharm.D., M.A.2, Jacqueline S. Marinac,Pharm.D.3; (1)UCSD, La Jolla, CA; (2)University of Illinois atChicago, Chicago, IL; (3)ACCP Research Institute, Lenexa, KS PURPOSE: Clinical pharmacists perform a variety of tasks related tomedication error (ME) detection, amelioration, and prevention.However, a national study that systematically describes theseinterventions has not been reported. One of our study objectives wasto describe MEs and clinical pharmacist interventions within anational clinical pharmacist practice based research network (PBRN). METHODS: Clinical pharmacists were recruited from the ACCPPBRN to report their interventions to detect, ameliorate, and preventMEs over a 14-consecutive day period in 2010. Participatingpharmacists viewed online training materials about reporting MEs andthe data collection tool. IRB approval was obtained from AAFP firstthen local institutions as needed. RESULTS: A total of 71 individual pharmacists submitted 924reports; however, only 782 reports had complete ME data. MEsoccurred in the inpatient (61%), outpatient (29%), home (7%), andother (3%) settings. Therapeutic categories associated with MEsfrequently reported were systemic anti-infective (25%), hematologic(21%), and cardiovascular (19%) medications. The top 5 frequentlyreported medications were antibiotics (n=172), oral anticoagulants(n=76), injectable anticoagulants (n=68), beta-blockers (n=37), andinsulin (n=29). Most MEs (95%) did not result in patient harm;however, MEs resulted in temporary harm (n=33), permanent harm(n=6), requiring interventions to sustain life (n=2), and death (n=1).The reported MEs were due to prescribing (54%), dispensing (10%),administering (13%), monitoring (13%), documenting (7%), andmiscellaneous (3%) errors. Pharmacist interventions includedcommunication (54%), medication change (35%), and monitoring(9%). Approximately 82% of pharmacist recommendations wereaccepted by prescribers (4% with modifications, 52% withoutmodifications, and 26% due to pharmacist prescriptive authority). CONCLUSION: Most MEs reported by US clinical pharmacists didnot result in patient harm; however, there were reports of severe harmand death. Half of the MEs detected were prescribing errors. Themajority of pharmacist recommendations to prevent or ameliorateMEs were accepted by prescribers.

171. Identifying and removing usage barriers of infusion smartpumps. Holly Herring, Pharm.D., Toni Ripley, Pharm.D., KevinFarmer, Ph.D.; The University of Oklahoma College of Pharmacy,

Oklahoma City, OK PURPOSE: Manual programming is a common cause of medicationerrors with infusion pumps. This can lead to patients receiving theincorrect dose or drug. Infusion smart pumps have safety features thathave been shown to decrease the incidence of medication errorscompared to manual programming. However, bypassing the smartpump safety feature is possible; studies suggest this safety feature isbypassed frequently. Obstacles to safety feature utilization have beendescribed, but no evidence for improving utilization rates exist. Wesought to quantify obstacles to utilizing this important technology andinvestigating the effectiveness of interventions to address theobstacles. METHODS: A comparison of smart pump safety feature utilizationon the cardiovascular service (CVS) before and after pharmacisteducation was conducted. The primary endpoint was change in 30-dayusage rate after pharmacist education. A 10-question paper survey wasdistributed to all part- and full-time nurses on the CVS by nursingadministration that targeted three domains that were potentiallimitations to using the technology (education/training, content, andburden of use). After baseline usage and survey data was obtained,targeted education was directed towards the obstacles cited from thenurses over a 4–6 week period. A repeat 30-day usage report wasobtained after intervention. RESULTS: Approximately 50–60 nurses were given the survey; 36were returned. Primary obstacles to using technology were comfortwith technology, motivation, and experience. After targeted educationand training, utilization rates of the smart pump safety featureincreased 5.5 times from baseline (5.4% versus 30.5%, P<0.000001). CONCLUSIONS: Targeting education and training to nurses’perceived barriers of smart pump technology is an effective way toimprove smart pump safety feature use, though overall utilization canstill be improved. Additional obstacles to safety feature use needs tobe investigated, including perceived time constraints andadministrative issues, such as nursing orientation and turn-over.

172E. Evaluation of risk factors for warfarin resistance followingadministration of vitamin K. Sheri J. VanOsdol, Pharm.D., HeatherJ. Ipema, Pharm.D., Edith A. Nutescu, Pharm.D.; University ofIllinois at Chicago College of Pharmacy, Chicago, IL PURPOSE: This study was conducted to evaluate the time to returnof therapeutic International Normalized Ratio (INR) followingwarfarin reinitiation in patients who received vitamin K for reversal ofexcessive anticoagulation and to identify factors associated withprolonged time to therapeutic INR. METHODS: Electronic medical records of adult patients whoreceived any dose or route of vitamin K from April 23, 2008 toOctober 23, 2009 were retrospectively analyzed. This subgroupanalysis was part of a larger project examining evidence-based use ofvitamin K for warfarin reversal at our institution. RESULTS: Of the 184 patients who received vitamin K during thestudy period, 42 patients were reinitiated on warfarin after receipt ofvitamin K (median age 63 years, 69% female, 66.7% AfricanAmerican). Only 8 (19%) of these patients received doses/routes ofvitamin K adherent with the 2008 ACCP guidelines. The median timebetween vitamin K receipt and reinitiation of warfarin was 68.5 hours;the median time between warfarin reinitiation and therapeutic INRwas 109.5 hours. A trend was noted between higher INR at time ofwarfarin reinitiation and shorter time to therapeutic INR. Statisticalanalysis did not reveal any correlations between patient- ormedication-related factors and time to therapeutic INR. CONCLUSION: Over-correction of supratherapeutic INR withvitamin K, indicated by a sub-therapeutic INR at the time of warfarininitiation, may increase the time to therapeutic anticoagulation,compared to those with therapeutic or near-therapeutic INR at time ofreinitiation. Adequately-powered studies are needed to identify factorsassociated with a prolonged time to therapeutic INR. Presented at Presented at the United HealthSystems ConsortiumMidyear Meeting, Anaheim, CA, December 5–9, 2010.

173. Evaluation of pharmacist decision making and opinionsinvolving prescriptions with a high probability of causing patientharm. Colleen S. Kann, Pharm.D.1, James D. Hoehns, Pharm.D.,FCCP, BCPS1, John E. Sutherland, M.D.2, James J. Poock, M.D.2;


(1)NEIMEF/University of Iowa College of Pharmacy, Waterloo, IA;(2)NEIFPC, Waterloo, IA PURPOSE: Adverse drug events related to medication dosage errorscan result in catastrophic patient outcomes. Little is known aboutpharmacist decision making when they are presented withprescriptions which contain an apparent overdosage. The objectivewas to evaluate if pharmacists would fill a prescription which containsan excessive dosage, even if the physician verified and approved theprescription. METHODS: A survey was sent electronically to pharmacists in Iowa.The survey presented prescription scenarios containing intentionalerrors in dosage or instruction. Examples included digoxin 0.25mgthree tablets daily, methotrexate 7.5 mg daily for rheumatoid arthritis,and transdermal fentanyl 100mcg in a patient with limited prior opioidusage. Pharmacists were instructed that the prescribing physician wasdirectly contacted about each prescription and that the physicianapproved the prescription as written. RESULTS: There were 599 evaluable surveys completed. Thefrequency of pharmacists who reported they would fill theprescriptions were: digoxin 18.5%, methotrexate 16.8%, and fentanyl37.9%. Hospital pharmacists were less likely to fill the prescriptionsthan community pharmacists. Nearly half of respondents felt theywere inadequately trained in their pharmacy education on how to dealwith prescriptions which they felt had significant potential for patientharm. CONCLUSION: Despite significant limitations to our survey,pharmacists often reported they would fill a prescription that wouldcommonly be viewed as highly inappropriate, provided that theprescriber verified the dosage as written. Pharmacy educationcurriculums should consider new strategies to educate pharmacistsabout minimizing harm to patients when they are presented with highrisk prescriptions.

Nephrology

174. Impact of pharmacist-managed erythropoiesis-stimulatingagents clinics for non-dialysis chronic kidney disease patients.Leah Flowers, Pharm.D.1, Sherrie Aspinall, Pharm.D., MSc2, FranCunningham, Pharm.D.3, Xinhua Zhao, Ph.D.4, Kenneth Smith, M.D.,M.S.5, Roslyn Stone, Ph.D.5, Chester Good, M.D., M.P.H.4, ESAClinic Study Group, -6; (1)G.V. (Sonny) Montgomery VA MedicalCenter, Jackson, MS; (2)VA Center for Medication Safety, Pittsburgh,PA; (3)VA Center for Medication Safety, Hines, IL; (4)VA PittsburghHealthcare System, Pittsburgh, PA; (5)University of Pittsburgh,Pittsburgh, PA; (6)VA Pharmacists, - PURPOSE: Veterans Affairs (VA) Medical Centers establishedpharmacist-managed ESA clinics to improve the use of erythropoiesis-stimulating agents (ESAs). To evaluate the effectiveness of theseclinics, we compared the quality of care provided by pharmacist-managed ESA clinics versus usual care in patients with non-dialysischronic kidney disease (ND-CKD). METHODS: Outpatients who were receiving ESAs for ND-CKD atten VA Medical Centers with a pharmacist-managed ESA clinic(n=314) and at six sites with physician-based care (i.e., usual care;n=167) on January 1, 2009 were followed for 6 months. The primaryoutcome measures were patient-days in the hemoglobin target range of10–12 g/dl, ESA dose and frequency of hemoglobin monitoring. Weidentified factors associated with hemoglobin values below and abovetarget range using multinomial logistic regression, adjusted forclustering at the patient level. RESULTS: More patient-days were in the target hemoglobin range inthe pharmacist-managed clinic (75.8% versus 59.3% for usual care;p<0.0001). The median 30-day dose of darbepoetin was 107 mcg inthe pharmacist-managed group versus 136 mcg in usual care (p=0.02);the corresponding medians for epoetin were 29643 IU versus 42857IU (p=0.27). Veterans in the pharmacist-managed group had morehemoglobin measurements on average (5.8 versus 3.6 in usual care;p<0.0001). In the multinomial model, glomerular filtration rate <15ml/min/1.73m2 was associated with increased odds of a hemoglobinvalue below target (reference 30–60 ml/min/1.73m2; AOR 1.81;95%CI 1.07, 3.15); usual care was associated with increased odds of ahemoglobin above target (AOR 2.48; 95%CI 1.52, 4.06), and heartfailure was associated with decreased risk of values below and above

target (AOR 0.76; 95%CI 0.58–0.99). CONCLUSIONS: Relative to usual care, pharmacist-managed ESAclinics provided improved quality of care for Veterans with ND-CKD(i.e., more time in the target hemoglobin range, lower ESA doses andmore frequent hemoglobin monitoring).

175. Effects of dual blockade of the renin angiotensin system indiabetic kidney disease: a systematic review and meta-analysis.Jacqueline T. Pham, Pharm.D., David J. Leehey, M.D., Brian P.Schmitt, M.D., M.P.H.; Edward Hines JR VA Medical Center, Hines,IL PURPOSE: There is much evidence to support a renoprotective effectof inhibitors of the renin- angiotensin system in diabetic kidneydisease. However, it remains unclear whether dual renin- angiotensinsystem blockade has additional benefits in this population and whetherany benefits outweigh the risks. METHODS: Study Design: Systematic review and meta-analysisSetting and Population: Diabetic patients with overt proteinuriaSelection Criteria for Studies: Randomized, controlled, parallel orcrossover design studies Intervention: Combination renin-angiotensinsystem blockade vs. monotherapy Outcomes: The primary outcomemeasure was the post-treatment difference in proteinuria withcombination therapy versus monotherapy. Secondary outcomesincluded percent change in proteinuria, changes in systolic bloodpressure, glomerular filtration rate, and serum potassium, andincidence of hyperkalemia. Sensitivity analyses that evaluateddifferences in outcome based on study quality (assessed by Jadadscores), baseline systolic blood pressure, and drug types and doseswere conducted. RESULTS: There was significantly less proteinuria (by 334 mg/24 hr)after treatment with combination therapy vs. monotherapy. Systolicblood pressure (BP) after treatment with combination therapy vs.monotherapy was significantly lower (by 4.1 mmHg). However,clinically significant hyperkalemia was 3.5-fold more common withdual blockade. Sensitivity analyses did not identify subgroupdifferences that altered these findings. CONCLUSIONS: Dual renin-angiotensin system blockade in patientswith diabetic kidney disease reduces proteinuria and BP but isassociated with a higher incidence of clinically significanthyperkalemia. Further studies assessing long-term outcomes areneeded to weigh the benefits versus risks of combination renin-angiotensin system inhibitor therapy.

176E. Evaluation of the MDRD and Cockroft-Gault equations forsitagliptin dosing. Joanna Q. Hudson, Pharm.D.1, M. ShawnMcFarland, Pharm.D.2, Brandon M. Markley, Pharm.D.3, Paul Patel,M.D.4; (1)University of Tennessee Dept of Clinical Pharmacy,Memphis, TN; (2)Alvin C. York Veterans Administration,Murfreesboro, TN; (3)University Medical Center of Southern Nevada,Las Vegas, NV; (4)Murfreesboro Medical Clinic, Murfreesboro, TN PURPOSE: The MDRD equation is now advocated along with theCockcroft-Gault (CG) equation for drug dosing. Currently doserecommendations by manufacturers are based on estimated creatinineclearance (eCrCl) determined by CG. Few studies have evaluateddifferences in dosing using MDRD and CG. Sitagliptin is a dipeptidylpeptidase IV used for type 2 diabetes mellitus (T2DM) with doseadjustments based on eCrCl. We assessed discordance rates in initialsitagliptin doses recommended using MDRD and CG. METHODS: Adult patients with T2DM prescribed sitagliptin in theoutpatient clinic Oct 2006-June 2009 were included. Estimated GFR(eGFR) and eCrCl were calculated by the 4-variable MDRD and CGequations, respectively. Sitagliptin dose based on manufacturer’slabeling was determined. Discordance in doses recommended usingMDRD and CG estimates were compared overall and by subgroupbased on eCrCl category (eCrCl >50, 30–50, and <30 mL/min). RESULTS: A total of 121 patients were included; 52% male; 90%Caucasian; mean age 61±12 yrs; weight 93±19 kg; ideal body weight61±10 kg; BSA 2.0±0.22 m2. Mean eGFR was 76±19 mL/min andeCrCl was 68±17 mL/min. Discordance in sitagliptin dose was observedin 11 patients (9%) with MDRD compared to CG. Discordance bysubgroup was as follows: 1/2 (50%) for eCrCl < 30; 8/10 (80%) foreCrCl 30-50, and 2/109 (2%) for eCrCl > 50 mL/min. All patients witheCrCl < 50 would have received a higher dose using MDRD while

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patients with eCrCl > 50 would have received a lower dose. CONCLUSION: Overall there was agreement in initial sitagliptindose using MDRD and CG. Discrepancies resulted in underestimationof sitagliptin dose at eClCr above 50 mL/min and overestimation atlower eClCr. Clinical implications are the potential for excessivedosing for individuals with kidney dysfunction. Since many agentshave similar dosing stratification by eCrCl, this pattern is likely forother renally eliminated agents. Published in J Am Soc Nephrol 2010;21:184A. Presented at theAmerican Society of Nephrology Meeting, Denver, CO. November18, 2010.

177E. Effects of a-lipoic acid on oxidative stress in ESRD patientsreceiving IV iron. Arif Showkat, M.D., FASN1, Joanna Q. Hudson,Pharm.D., FASN2, William Bastnagel, M.D.1; (1)University of TNCollege of Medicine, Memphis, TN; (2)University of TennesseeCollege of Pharmacy, Memphis, TN PURPOSE: Oxidative stress is associated with increased risk ofcardiovascular disease in ESRD patients. Intravenous (IV) ironincreases oxidative stress in this population. The purpose of the studywas to evaluate changes in oxidative stress markers followingadministration of IV sodium ferric METHODS: ESRD patients who met inclusion were enrolled in thisopen-label, crossover study. During a control (C) and intervention (I)visit 125 mg IV SFG was administered over 10 minutes. During

RESULTS: Ten African-American ESRD subjects were enrolled; 5males; mean age 45±9 yrs; mean Hb13±1 g/

Table 1: % Change in Markers Time (min) 60 90 120 180 MDA-C 21.7±26.5 19.4±30.5 22.3±38.7 19.6±39.0 MDA-I 72.1±96.3* 66.7±70.6* 60.6±60** 65.9±69.3** FIP-C 13.8±20.7 19.5±17.5 7.7±21.1 10.8±15.9 FIP-I 56.8±32.4** 37.6±28.7 38.9±40.4** 19.9±34.0 LHP-C 23.5±13.2 16.2±10.0 9.4±10.4 5.1±6.1 LHP-I 37.4±18.0** 28.7±15.3** 23.1±13.1** 14.8±8.4**Mean ± SD. MDA & LHP: µmol/L, FIP: pg/mL *P≤0.01, ** 0.01>P≤0.05 compared to C group.CONCLUSION: Administration of IV SFG is associated with anacute rise in oxidative stress. In contrast to previous studies,administration of an antioxidant was associated with a greater increasein oxidative stress. Published in J Am Soc Nephrol Abstracts Issue 2010;21:722A.Presented at the American Society of Nephrology Meeting, Denver,CO. November 20, 2010.

Neurology

178E. Rasagiline and antidepressant use in patients withParkinson’s Disease: assessing the occurrence of serotonin toxicity.Jack J. Chen, Pharm.D.1, Michel Panisett, M.D.2, Sean Rhyee, M.D.,M.P.H.3; (1)Loma Linda University, Loma Linda, CA; (2)Notre-DameHospital-CHUM, Montréal, QC, Canada; (3)University ofMassachusetts Medical School, Worcester, MA PURPOSE: Use of nonselective monoamine oxidase (MAO)inhibitors concomitantly with antidepressants has been associated withserotonin toxicity (ST), a potentially life-threatening syndromecharacterized by clonus and autonomic dysfunction and requiresimmediate medical attention. Although rasagiline is a selective MAO-B inhibitor, the prescribing information for rasagiline contains awarning about the risk of ST with concomitant antidepressants. Thisstudy assesses the occurrence of ST in patients with Parkinson disease(PD) treated with antidepressants and rasagiline. METHODS: Multicenter, retrospective study of PD patients whobegan receiving rasagiline with antidepressants (R+AD), rasagilinewithout antidepressants (R), or antidepressants with dopaminergictherapy not including rasagiline or selegiline (AD) between 9/1/2006and 12/31/2008. After collection of information on patientdemographic characteristics, treatment history, andhospitalizations/emergency room (ER) visits, attempts were made toobtain hospital records for patients with ≥1 hospitalization/ER visit.Records were sent to an independent adjudication committeeconsisting of an emergency medicine physician, a clinical

pharmacist/pharmacologist, and a movement disorders specialist. Thecommittee used published criteria to review records for the occurrenceof ST only in patients for whom full records were obtained for eachhospitalization/ER visit. RESULTS: Among 37 US sites, records of 1507 patients (R+AD,471; R, 511; AD, 525) were identified. Mean (SD) age was 67 (11)years; mean (SD) time from PD diagnosis was 5.1 (5.8) years. Amongthe 195 patients (13%) who had ≥1 hospitalization/ER visit, 145patients had complete hospital records available. Hospitalizations/ERvisits for these 145 patients totaled 60 for R+AD, 50 for R, and 184for AD. No occurrences of ST were found in any group. CONCLUSION: No instances of ST among patients with completerecords for each hospitalization/ER visit were found by anindependent adjudication committee. Thus, the combined use ofrasagiline and antidepressants was not associated with ST in thismulticenter retrospective study. Published in Published in Neurology 2011;76(suppl4):A539.

179. Increased frequency and duration of elevated blood pressuremeasurements after IV thrombolytics for ischemic stroke is notassociated with increased risk of symptomatic intracerebralhemorrhage. Meghan E. Groth, Pharm.D., Ashis H. Tayal, M.D.,Melissa Tian, RN, Jillian M. Szczesiul, Pharm.D.; Allegheny GeneralHospital, Pittsburgh, PA PURPOSE: Acute ischemic stroke (AIS) guidelines include specificrecommendations for managing blood pressure (BP) in patients treatedwith IV thrombolytics and subsequently aim to reduce hemorrhagiccomplications. However, data assessing the relationship between BPmanagement surrounding IV thrombolytic therapy and the risk ofhemorrhage is limited. We hypothesized that an increase in frequencyor duration of elevated BP after IV thrombolytics would be associatedwith an increased risk of symptomatic intracerebral hemorrhage(sICH). METHODS: Patients treated with IV tissue plasminogen activator(tPA) at our institution over a three year period were reviewed forelevated BP measurements recorded during the 24 hours followingtherapy. Measurement of sICH was determined by the neurologist’sinterpretation of head computed tomography findings. Patients wereexcluded if they were > 89 years of age, received tPA intra-arterially,or under a violation of institutional protocol. Ordinal logisticregression and c2 methodology were used for primary objectiveanalysis. RESULTS: A total of 144 patients were included; 112 patients did nothave a documented bleed while 32 patients had a documented bleed (5were classified as sICH). An increased frequency of elevated BPmeasurements was not associated with an increased risk of sICH (c2=7.378, p=0.061 for SBP; c2 = 1.088, p=0.780 for DBP). Similarly, anincreased duration of elevated BP measurements was not associatedwith an increased risk of sICH (c2 = 8.066, p=0.153 for SBP; c2 =1.088, p=0.896 for DBP). Overall frequency and duration of elevatedBP was low, and the majority of patients (83%) did not require anti-hypertensive medications to lower baseline BP. CONCLUSION: Neither frequency nor duration of elevated BPmeasurements was associated with an increased risk of sICH. Theseresults should be confirmed in a prospective manner among a largerpatient population.

Oncology

180. Impact of antiemetic regimens adherence on nausea andvomiting control among Asian breast cancer patients receivinganthracycline-based chemotherapy. Alexandre Chan, Pharm.D.,M.P.H.1, Rachel Ong, BSc(Pharm)Hon1, Xiu Hui Low, BSc(Hon)1,Kevin Yap, Ph.D.2; (1)National University of Singapore, Singapore,Singapore; (2)University of Warwick, Coventry, United Kingdom PURPOSE: This study was conducted to evaluate the impact ofadherence to delayed antiemetic regimens on chemotherapy inducednausea and vomiting (CINV) control in breast cancer patients, and toidentify patient characteristics that may be associated with non-adherence to antiemetic regimens. METHODS: This was a prospective, observational study conductedat the largest ambulatory cancer center in Singapore from December2006 to January 2011. All breast cancer patients receiving


anthracycline-based chemotherapy and standardized outpatientantiemetic regimens were recruited. On the day of chemotherapy,patients were given a standardized 5-day diary to document theiremesis events and their demographics obtained via interview.Pearson’s c2 test and multiple logistic regression were performed toanalyze the impact of adherence on CINV control. RESULTS: 361 eligible patients were included in the final analysis(mean=50.0±8.9 years). Majority of the patients were Chinese(80.1%) and diagnosed with Stage 2 and above breast cancer (88.1%).Almost half of the patients (42.1%) were non-adherent to theirprescribed delayed antiemetics regimens, with dexamethasone usagebeing the least adhered to (non-adherence: 37.4%). After adjusting forpotential confounders (ethnicity, education level and stage of disease),patients who were adherent to antiemetics were more likely to achievecomplete CINV control (defined as no emetic episodes, no nausea, andno rescue therapy required) than patients who were non-adherent(NNT=9.6; Adjusted OR=1.74, 95% CI: 1.01–3.01). In addition,young women aged between 21–40 years old, pursued highereducation, and diagnosed with Stage 1 breast cancer were associatedwith non-adherence to antiemetics (p<0.05). CONCLUSION: This is the largest study to date to evaluate theprevalence of non-adherence to delayed antiemetics among Asianbreast cancer patients. Our findings indicate that a substantial amountof Asian breast cancer patients (42.1%) were not adherent to theirantiemetic regimens, which have resulted into poor control of CINV.

181. Characteristics and clinical course of pediatric patientsadmitted with chemotherapy-related febrile neutropenia. Suha M.Al-Omar, Pharm.D., Lama H. Nazer, Pharm.D., BCPS; King HusseinCancer Center, Amman, Jordan PURPOSE: To describe the characteristics and clinical course ofpediatric patients admitted with febrile neutropenia (FN) related tochemotherapy. METHODS: This was a 6-month prospective observational studyconducted between October, 2010 and March, 2011 at acomprehensive academic cancer center. Patients admitted to thepediatric medical ward with FN were included. Patient demographics,duration since last chemotherapy, use of granulocyte colonystimulating factor (G-CSF), presence of an indwelling central venouscatheter (CVC), transfer to the intensive care unit (ICU), length ofstay, and mortality were recorded. In addition, the results of allcultures obtained were reviewed. RESULTS: During the study period, 117 cases were included: 78patients (66.7%) had hematological malignancies, while the remaininghad solid tumors. Of the patients enrolled, 62 (53%) were females andthe average age was 7.1± 5.06 (SD) (range 1–19) years. The meanduration since last chemotherapy was 7.78 ±7.56 (SD) days, the meanduration of hospital stay was 9.38 ±9.6 (SD) days, and transfer to theICU was required for 12 (10.3%) patients but there were no reporteddeaths. Positive cultures were reported in 23 (19.7%) patients. Thepathogens isolated were gram-positive organisms (n=12; 52.2%)which were mainly coagulase-negative staphylococcus species, gram-negative organisms (n=5; 21.7%), viral (n=5; 21.7%) and fungal (n=1;4.3%). The presence of CVC was significantly more in patients withdocumented infections compared to patients with fever of unknownorigin (FUO): 52.2% versus 29.8%, respectively (P= 0.04). Therewere no significant differences between patients with positive culturesand those with FUO in the age, presence of G-CSF, length of hospitalstay, and transfer to the ICU. CONCLUSION: About 80% of the pediatric patients admitted withFN had FUO. Developing risk-stratified management of FN mayreduce unnecessary admissions. The pathogens reported in this patientpopulation differ from those reported in previous studies.

182E. ENESTnd 24-month follow-up of nilotinib versus imatinibin patients with newly diagnosed chronic myeloid leukemia inchronic phase. Gerry Gorospe, III, RN, BSN, PHN, MSN1, Hagop M.Kantarjian, M.D.2, Andreas Hochhaus, M.D.3, Richard A. Larson,M.D.4, Giuseppe Saglio, M.D.5, Timothy P. Hughes, M.D.6; (1)City ofHope, Duarte, CA; (2)University of Texas MD Anderson CancerCenter, Houston, TX; (3)Hamatologie und internistische Onkologie,Universitatsklinikum Jena, Jena, Germany; (4)University of ChicagoMedical Center, Chicago, IL; (5)University of Turin, Ospedale San

Luigi Gonzaga, Orbassano-Turin, Italy; (6)Royal Adelaide Hospital,Adelaide, SA, Australia PURPOSE: This analysis evaluated 24-month follow-up outcomedata of nilotinib versus imatinib from ENESTnd in patients withnewly diagnosed Philadelphia chromosome-positive chronic myeloidleukemia in chronic-phase (CML-CP). METHODS: In ENESTnd, 846 CML-CP patients were randomized tonilotinib 300 mg twice daily (BID; n = 282), nilotinib 400 mg BID (n= 281), or imatinib 400 mg once daily (n = 283). We report minimum24-month major molecular response (MMR; ≤0.1% BCR-ABLIS),overall best molecular response, complete molecular response (CMR4

[≤0.01% IS]) and CMR4.5 [≤0.0032% IS]), progression to acceleratedphase (AP)/blast crisis (BC), progression-free survival (PFS), andoverall survival (OS). RESULTS: With minimum 24-month follow-up, MMR rates weresignificantly superior with nilotinib 300 mg BID (71%) and 400 mgBID (67%) versus imatinib (44%; both P<0.0001) across all Sokal riskgroups. Compared with imatinib, nilotinib 300 mg and 400 mg BIDachieved significantly higher CMR4 (44%, 36% vs 20%; bothP<0.0001) and CMR4.5 rates (26%, 21% vs 10%; both P≤0.0004).There were significantly fewer progressions to AP/BC (includingclonal evolution) on nilotinib 300 mg BID (P=0.0003) and 400 mgBID (P=0.0089) compared with imatinib. At 24 months, PFS wassuperior with nilotinib 400 mg BID versus imatinib (P=0.0437). OSwas similar in all groups, but there were fewer CML-related deaths onboth nilotinib 300 mg BID (n = 5) and 400 mg BID (n = 3) versusimatinib (n = 10). The OS rate (CML-related death) was superior withnilotinib 400 mg BID versus imatinib (P=0.0485). Both drugs werewell tolerated with comparable rates of discontinuation due to adverseevents/lab abnormalities for nilotinib 300 mg and 400 mg BID versusimatinib (9%, 13%, and 10%, respectively). CONCLUSION: Nilotinib demonstrated superior efficacy withsignificantly improved disease control vs imatinib in newly diagnosedCML-CP patients. Presented at the 2011 American Society of Clinical Oncology AnnualMeeting, June 3–7, 2011 (ASCO 2011), Chicago, Illinois, USA;abstract 6511

183E. Deeper responses achieved with switch to nilotinib inpatients with Philadelphia-positive chronic myeloid leukemia inchronic phase with suboptimal molecular response to imatinib.Susan Strauch, R.Ph., BCOP1, Carole Miller, M.D.1, SikanderAilawadhi, M.D.2, Anand Jillella, M.D.3, Jerald Radich, M.D.4, DanielDeAngelo, M.D.5, Stuart Goldberg, M.D.6, Solveig Ericson, M.D.7,Felice Lin, Pharm.D.7, Luke Akard, M.D.8; (1)Saint Agnes Hospital,Baltimore, MD; (2)USC/Norris Comprehensive Cancer Center, LosAngeles, CA; (3)Medical College of Georgia, Augusta, GA; (4)FredHutchinson Cancer Research Center, Seattle, WA; (5)Dana-FarberCancer Institute, Boston, MA; (6)John Theurer Cancer Center,Hackensack, NJ; (7)Novartis Pharmaceuticals Corporation, EastHanover, NJ; (8)Indiana Blood and Marrow Transplantation, BeechGrove, IN PURPOSE: Treatment response in chronic myeloid leukemia (CML)is assessed by cytogenetics and molecular monitoring; achievement ofcomplete cytogenetic response (CCyR) and major molecular response(MMR) are favorable prognostic factors. The purpose of this study isto evaluate the impact of nilotinib on change in BCR-ABL levels andrate of MMR in patients with suboptimal molecular response toimatinib. METHODS: In this ongoing open-label study, CML patients inchronic phase (CML-CP) are included if they achieved CCyR but notMMR and received imatinib >1 year, or experienced >1-log increasein BCR-ABL levels from best response regardless of imatinibtreatment duration. All patients receive nilotinib 300 mg twice dailywith dose adjustments per protocol. MMR is measured by quantitativereverse transcriptase polymerase chain reaction analysis (RQ-PCR). RESULTS: Fourteen patients were enrolled as of June 30, 2010; 86%of evaluable patients achieved MMR at any time on study and 71%after 1 year on study. The median BCR-ABL log reduction for patientswho reached 12 months on study was 3.66 from the standardizedbaseline (BCR-ABL = 0.022% International Standard). Nilotinib waswell tolerated; most adverse events were adequately managed by doseinterruptions.

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CONCLUSION: These results of this ongoing study suggest thatchanging treatment to nilotinib results in an improvement of molecularresponse and is generally well tolerated in CML-CP patients withsuboptimal response to imatinib. Presented at This study was previously presented at the 52ndAmerican Society of Hematology Annual Meeting, Orlando, Florida,December 6, 2010 (ASH 2010); Abstract 2301

184E. Association Between Chronic Myeloid Leukemia TreatmentResponses and Patient Satisfaction, Functioning, and Quality ofLife: Patient Survey Results. Stuart Goldberg, M.D.1, Vamsi Bollu,Ph.D.2, Robert Morlock, Ph.D.3, Aleksandr Niyazov, Pharm.D.2, AmyGuo, Ph.D.2, Elias Jabbour, M.D.4; (1)John Theurer Cancer Center,Hackensack, NJ; (2)Novartis Pharmaceuticals Corporation, EastHanover, NJ; (3)i3 Innovus, Eden Prairie, MN; (4)The University ofTexas MD Anderson Cancer Center, Houston, TX PURPOSE: To assess awareness of the chronic myeloid leukemia(CML) patient of treatment response categorizations and theassociation between treatment responses and satisfaction, functioning,and quality of life (QOL) METHODS: CML patients participated in an online survey(Association for Cancer Online Resources) consisting of questions onpatient demographics, CML disease history, and awareness oftreatment responses. Current health status information was collectedusing a 5-item Likert scale question and a health status thermometer.Statistical comparisons were made by means of Chi-square, Fisher’stest, and multivariate regressions. RESULTS: Overall, 123 patients responded to the survey. The meanage of respondents was 63 years (range 20–86), 49% were male, and96% had some level of college experience. The median duration ofCML diagnosis was 8 years. Nearly all respondents reported beingcurrently in complete hematological response, 71% in completecytogenetic response (CCyR) and 68% in major molecular response(MMR). In this educated population, 90% of respondents were awareof different CML treatment response categories. However, 71.5%believed CML patients need more information on the types ofresponses; respondents believed information should come from theirphysicians (67%) versus other staff (28%) or pamphlets (24%).According to respondents, achieving MMR generates the greatestimprovement in daily functioning (86%), satisfaction with medication(87%), satisfaction with physician (79%), and outlook on life (86%).Patients achieving MMR had a significantly higher overall self-reported health status versus patients in CCyR (P=0.032). CONCLUSION: From a patient’s perspective, achieving MMR is animportant milestone associated with improved satisfaction with theirphysician, medication, daily functioning, and outlook on life. Higheroverall self-reported health status was reported by respondents inMMR than CCyR. Presented at Presented at the 2011 American Society of ClinicalOncology Annual Meeting, June 3–7, 2011 (ASCO 2011), Chicago,Illinois, USA; abstract 6614

185E. Adherence patterns and dose adjustments with second-linenilotinib and dasatinib in patients with chronic myeloid leukemia:evaluation in a real-world setting. Annie Guerin, MSc1, Vamsi Bollu,Ph.D.2, Amy Guo, Ph.D.2, James D. Griffin, M.D.3, Andrew P. Yu,Ph.D.1, Eric Wu, Ph.D.1; (1)Analysis Group, Boston, MA; (2)NovartisPharmaceuticals Corporation, East Hanover, NJ; (3)Dana-FarberCancer Institute, Boston, MA PURPOSE: To compare adherence, dose adjustments, and treatmentinterruptions associated with second-line nilotinib and dasatinib in areal-world setting. METHODS: Adult patients with chronic myeloid leukemia (CML)receiving second-line nilotinib or dasatinib were identified frommedical and pharmacy records (MarketScan and Ingenix Impact).Patients receiving ≥1 prescription and enrolled in their health planthroughout the 6-month study period were eligible. Adherence wasmeasured by the proportion of days covered (PDC) based onprescriptions filled. Medication possession ratios (MPRs) anddiscontinuation rates were also evaluated. Dosage characteristics,including dose changes, were calculated. RESULTS: Adherence and dose adjustments were determined forpatients receiving dasatinib (452 and 447 patients, respectively) or

nilotinib (69 and 67 patients, respectively). The mean PDC fordasatinib was lower compared with nilotinib (0.69 vs 0.79,respectively). After adjusting for confounding factors (eg, age, gender,CML disease complexity), the dasatinib group had a significantlylower PDC (approximately 13%) compared with the nilotinib group(P=0.0086). MPRs were also significantly lower with the dasatinibgroup versus the nilotinib group (0.75 vs 0.85, P=0.029). Moredasatinib-treated patients had at least 1 dose reduction ≥15%compared with nilotinib-treated patients (19.9% vs 6.0%; P=0.0057).Overall, dose decreases occurred within 30 days of a hematological ornon-hematological event in 49.5% of patients. CONCLUSION: In this analysis, CML patients treated with nilotinibfor second-line treatment were significantly more adherent to therapyand required fewer dose reductions than did patients receivingdasatinib. Presented at Presented at the 15th Annual International Congress onHematologic Malignancies (ICHM 2011); Whistler, British Columbia,Canada; February 17–20, 2011; poster #6

186E. A survey of current practices in the management of chronicmyeloid leukemia. Michael Mauro, M.D.1, Jorge Cortes, M.D.2,Richard A. Larson, M.D.3, Peter M. Herout, Pharm.D.4, Vamsi Bollu,Ph.D.5, Aleksandr Niyazov, Pharm.D.5, Amy Guo, Ph.D.5, Hagop M.Kantarjian, M.D.6; (1)Knight Cancer Institute at Oregon Health &Science University, Portland, OR; (2)The University of Texas MDAnderson Cancer Center, Houston, TX; (3)University of ChicagoMedical Center, Chicago, IL; (4)EPI-Q, Inc., Oak Brook, IL;(5)Novartis Pharmaceuticals Corporation, East Hanover, NJ;(6)University of Texas MD Anderson Cancer Center, Houston, TX PURPOSE: This analysis evaluated physician self-reported practicepatterns in the management of chronic myeloid leukemia-chronicphase (CML-CP). METHODS: We conducted a US-based survey via an onlinequestionnaire consisting of items updated to reflect changes in clinicalpractice, tyrosine kinase inhibitor (TKI) therapy, and currentguidelines. RESULTS: 507 board-certified medical oncologists/hematologistsresponded to the survey; 72% were in private practice. For initialtherapy, nearly 60% of respondents chose various doses of imatinib;40% chose nilotinib or dasatinib. Respondents believed achievingcomplete cytogenetic response (CCyR) at 6 or 12 months (32.5%) orboth CCyR and major molecular response (MMR) at 12 months(23.3%) was indicative of effective initial TKI therapy. Completemolecular response (CMR; 44%) and MMR (27%) were consideredprimary treatment goals. Marrow-based tests were used by <50% ofrespondents for initial monitoring; nearly 50% cited uncertainty orunfamiliarity with international scale (IS) reporting of qPCR.Regarding suboptimal response, 26% of respondents would maintainimatinib 400 mg daily in a patient achieving CCyR but not MMR after2 years of therapy; 34% would switch to nilotinib/dasatinib, and 52%would increase imatinib dose. Respondents were more likely tochange from imatinib to nilotinib/dasatinib for failure to achieveMMR after imatinib for 2 years, or perceived treatment failure onimatinib. For a patient not in CCyR, 74% would monitor response bycytogenetic studies every 3–6 months. For a patient in CCyR, 85%would monitor response by molecular studies every 3–6 months. Aslight majority (54%) would assess for BCR-ABL mutations if MMRis not achieved after 2 years of TKI; up to 30% of respondents usemutation analysis with initial diagnostic studies. CONCLUSION: Achieving at least MMR is the predominanttreatment goal in CML-CP; most respondents would adjust imatinibdose or change therapy to nilotinib or dasatinib to achieve MMR evenafter CCyR. Presented at Presented at the 2011 American Society of ClinicalOncology Annual Meeting, June 3–7, 2011 (ASCO 2011), Chicago,Illinois, USA; abstract 6513

187. Evaluation of gemcitabine modulation of multidrugresistance in cisplatin resistant human ovarian cancer cell line.Judith A. Smith, Pharm.D., BCOP, FCCP, FISOPP1, Anjali Gaikwad,M.S2, Amanda Hanks, B.S3, Robert Coleman, M.D.4; (1)UT M. D.Anderson Cancer Center, Houston, TX; (2)The UT MD AndersonCancer Center, Houston, TX; (3)The UT Health Science Center at


Houton Graduate School of Biomedical Sciences, Houston, TX;(4)The University of Texas, M.D. Anderson Cancer Center, Houston,TX PURPOSE: To evaluate the gemcitabine modulation of multidrugresistance in cisplatin resistant human ovarian cancer cell line TOV-112D-CR. METHODS: TOV-112D was developed into a cisplatin resistant cellline (TOV-112D-CR) through sequential exposure to increasingconcentrations of cisplatin. Markers of multi-drug resistance (MDR)were evaluated in both cell lines including SXR, GST-1, P-GP, MDR,p53 and Bcl-2 by Western Blot. MDR was confirmed by in vitrogrowth inhibition assays conducted in cisplatin sensitive and resistantcell lines with selected chemotherapy agents. Gemcitabine modulationof MDR was evaluated with sequential combination growth inhibitionassays conducted in both cell lines. RESULTS: Induced cisplatin resistance was confirmed by a 13-foldincrease in the IC50 (4.2µg/mL vs. 0.32 µg/mL, p<0.001). Crossresistance to other chemotherapy agents was confirmed by a 1.5–3fold increase in the IC50. The combination growth inhibition assayswith gemcitabine confirmed the role of gemcitabine in reversingresistance to cisplatin, doxorubicin and topotecan. No improvementwas observed with gemcitabine plus paclitaxel or docetaxel.Furthermore, sequential for 72 hour treatment with gemcitabinefollowed by other selected chemotherapy demonstrated modulation ofdrug resistance improved by mean of 60% (28.4–95.3%), (p<0.01)compared to combination treatment. The treatment of TOV-112D-CRwith gemcitabine also showed a time dependent down regulation ofMDR1 and GST-1 and up regulation of wild type p53, associated withincrease in drug sensitivity. CONCLUSION: These data suggest a positive correlation betweencisplatin resistance and MDR in human ovarian cancer cell line.Gemcitabine modulation of MDR was demonstrated in these in vitrostudies by the reversal of the resistance with four chemotherapyagents. The potential benefits of incorporating gemcitabine incombination with selected chemotherapy agents into the treatment ofrecurrent MDR ovarian cancer will be pursued with confirmatory invivo studies.

188. Evaluation of adverse drug events associated with liposomaldoxorubicin in patients with renal insufficiency treated forgynecologic malignancies. Justin Julius, Pharm.D.1, GracielaNogueras-Gonzalez, M.P.H.1, Judith K. Wolf, M.D.2, Judith A. Smith,Pharm.D., BCOP, FCCP, FISOPP3; (1)The UT MD Anderson CancerCenter, Houston, TX; (2)The University of Texas, M.D. AndersonCancer Center-Dept of Gynecologic Oncology, Houston, TX; (3)UTM. D. Anderson Cancer Center, Houston, TX PURPOSE: Determine the impact of renal insufficiency on theincidence of adverse drug effects (ADEs) in patients receivingpegylated liposomal doxorubicin (PLD) for treatment of gynecologicmalignancies. METHODS: A retrospective chart review was conducted from adatabase of women with gynecologic malignancies treated with PLDbetween 1996 and 2006. Data collected included patientdemographics, PLD dosing, ADEs, serum creatinine, diseaseprogression and survival. Renal insufficiency was defined as anestimated creatinine clearance < 60 mL/min. Logistical regressionanalysis was used to identify patient characteristics associated withhigher incidence of ADE and which influenced survival. RESULTS: A total of 467 patients were identified that received PLDfor gynecologic malignancies between 1996 and 2006. The meannumber of PLD cycles received was 4.2 (range 1–29). 187 (40%)patients had an estimated creatinine clearance of < 60 mL/min. Themost commonly reported adverse effects include nausea (32.8%),vomiting (16.7%), mucositis (20.1%), neutropenia (19.5%), palmar-plantar erythrodysesthesia (PPE) (31.5%), peripheral neuropathy(22.7%), and muscle pain and weakness (13.7% and 19.1%). Of theADEs listed vomiting was more common in patients with renalinsufficiency (21.7%) versus those with normal renal function (13.3%,p=0.017). In the logistic regression an odds ratio of 1.80 (1.11–2.94p=0.018) was observed for the association between vomiting and CrCl< 60mL/min. A decrease in peripheral neuropathy was observed inpatients with renal insufficiency with an odds ratio of 0.59 (0.37, 0.94p=0.027). There was no difference in time to progression (TTP) or

overall survival (OS) based on dose level of PLD between 25 mg/m2

and 50 mg/m2 received. CONCLUSIONS: PLD is associated with increased ADEs in patientswith poor renal function. Dose adjustments may be warranted inpatients with renal insufficiency being treated for recurrentgynecologic cancers to decrease risk of toxicity. Dose level did notalter potential efficacy based on TTP/OS.

189. Thiopurine-associated tumorigenesis: using thiopurinemethyltransferase to identify important thioguanine-inducedphenotypes in astroglial cells. Amira Ahmed-Hosni, B.S.1, RobertRooney, Ph.D.2, Joseph Barnes, M.S.3, Jim Wan, Ph.D.4, Terreia Jones,Pharm.D.5; (1)University of Tennessee, Memphis; (2)GenomeExplorations, Memphis, TN; (3)University of Tennessee HealthScience Center, Memphis, TN; (4)University of Tennessee HealthSciences Center, Memphis, TN; (5)University of Tennessee, Memphis,TN PURPOSE: Thiopurines [i.e., thioguanine (TG), mercaptopurine] areantimetabolite drugs commonly used as anticancer andimmunosuppressive agents. Thiopurine methyltransferase (Tpmt) isthe primary enzyme responsible for deactivating thiopurine drugs andis subject to inter-patient variations in the level of protein expressed.Chronic thiopurine therapy has been linked to brain cancerdevelopment and Tpmt status has been associated with this risk.Thiopurine drug-induced DNA lesions and inadequate DNA repairprocessing have been implicated in tumorigenesis. METHODS: We investigated whether TG-induced cytotoxicity andthe extent of DNA damage in the form of single and double strandbreaks (SSBs, DSBs) could be predicted by Tpmt expression inastroglial cells. Additionally, we compared gene expression patterns ofcandidate genes involved in DNA damage repair between primaryastrocytes of each Tpmt genotype. RESULTS: We found that astroglial cells with low Tpmt activity(Tpmt +/- and Tpmt -/- astrocytes and A172) predicted a significantlylower IC50 than did astrocytes with high Tpmt activity (Tpmt +/+

astrocytes and T98). We also found that TG exposure inducedsignificantly more DNA damage in the form of SSBs in astroglial cellswith low Tpmt than in cells with high Tpmt. Interestingly, we foundthat Tpmt +/- had the highest degree of cytotoxicity and genotoxicityafter TG exposure compared to Tpmt +/+ and Tpmt -/- astrocytes.Expression studies revealed that several genes involved in the baseexcision and mismatch repair pathways had lower levels of expressionin Tpmt +/- and Tpmt -/- as compared to Tpmt +/+. Additionally, TGtreatment induced the expression of some DNA repair genes in Tpmt+/+ and Tpmt -/- but not in Tpmt +/- astrocytes. CONCLUSION: The results show that low Tpmt can lead to highTG-induced toxicity in astroglial cells. Our findings also suggest thatTpmt genotype may influence the DNA damage response after TGexposure.

Other

190. Qatar pharmacists’ understanding, attitudes, practice andperceived barriers related to providing pharmaceutical care.Maguy S. El Hajj, Pharm.D., Hassna S. Al Saeed, BSPharm, MaryamA. Khaja, BSPharm; Qatar University College of Pharmacy, Doha,Qatar PURPOSE: Pharmaceutical care (PC) is the philosophy of practicethat includes identifying, preventing and resolving medication therapyproblems to improve patient outcomes. The study objectives were toexamine the extent of PC practice and the barriers to PC provision asperceived by Qatar pharmacists and to assess their level ofunderstanding of PC and their attitudes about PC provision. METHODS: A cross sectional survey of Qatar pharmacists wasmade. All pharmacists in Qatar were phone called and requested toparticipate. Consenting pharmacists were given the option to completethe survey either online using an online survey software or as paperbased using fax. Data was descriptively analyzed using the StatisticalPackage of Social Sciences version 19. RESULTS: Over 8 weeks, 274 surveys were collected (34% responserate). More than 70% of respondents had correct understanding of thegoal and use of PC and of the pharmacist role in PC. However, only35% understood the patient role in PC and only 17% were aware of

363e


when to provide PC. Yet, more than 80% believed that they could beadvocates when it comes to patients’ medications and health mattersand that they were ready to make the commitment required to improvepatients’ outcomes. Concerning their PC practice, respondentsreported spending little time on PC activities. Offering feedback to thephysician about the patient progress and documenting PC activitieswere always or most of the time performed by less than 25% ofrespondents. The top perceived barriers for PC provision includedinconvenient access to patient medical information (78% ofrespondents) and lack of staff and time (77% and 74% respectively). CONCLUSION: Although PC is not incorporated into pharmacypractice, Qatar pharmacists showed good attitudes toward PCprovision. Efforts should be exerted to improve their understanding ofPC and to overcome all perceived barriers.

191. Endocrine and Metabolism PRN updates and report of thebenefit with an online journal club. Amy C. Donihi, Pharm.D.1,Rohit Moghe, Pharm.D.2, Emily Vescovi, Pharm.D.3, Jennifer N.Clements, Pharm.D.3, Rick Hess, Pharm.D.4, Craig Logemann,Pharm.D.5, Kent Porter, Pharm.D.6; (1)University of PittsburghMedical Center, Pittsburgh, PA; (2)Thomas Jefferson UniversityHospital, Philadelphia, PA; (3)Bernard J. Dunn School of Pharmacy,Shenandoah University, Winchester, VA; (4)Bill Gatton College ofPharmacy, Johnson City, TN; (5)Iowa Health, Des Moines, IA;(6)Sanofi-Aventis, Lantana, TX PURPOSE: The purpose is to describe current activities of theEndocrine and Metabolism (Endo-PRN) and member opinions on arecently initiated online journal club. METHODS: A five-question questionnaire was created usingSurveyMonkeyTM and the link to complete it was distributed tomembers of Endo-PRN via the PRN e-mail list-serve on December 3,2010 and was available for completion through December 15, 2010. Areminder email was sent via the PRN e-mail list-serve on December13, 2010. RESULTS: Of 224 active Endo-PRN members, 22 (10%) respondedto the questionnaire. One hundred percent agreed or strongly agreedthat the journal club includes worthwhile topics of interest, 86% thatquantity of journal club submissions per month is sufficient, and 71%that two journal club articles per week are sufficient. Journal club isread often or always by 50%, sometimes by 41%, and never by 9%.The majority (73%) reported that they have never submitted an articlefor the journal club. Open-ended comments were positive andsuggested improvements such as increasing participation from otherEndo-PRN members and possibly reducing the number of articlesposted each week. There was a low response rate to the survey;therefore, results may not fully represent the PRN membership. CONCLUSION: Based on the findings, the journal club has beenwell received, but all members do not contribute. A repeat survey willbe done in Fall 2011. For the Endo-PRN, other activities haveincluded its first opinion paper discussing cancer risk with insulinglargine, growth in membership, and updated policies and proceduresfor future projects.

192. Factors that influence board certification among pharmacypractice faculty in the US. Kristin Watson, Pharm.D., BCPS1,Kimberly A. Toussaint, Pharm.D.2, Joel C. Marrs, Pharm.D., BCPS3,Deborah A. Sturpe, Pharm.D., BCPS1, Sarah L. Anderson, Pharm.D.,BCPS3, Stuart T. Haines, Pharm.D., BCPS1; (1)University ofMaryland School of Pharmacy, Baltimore, MD; (2)University ofMaryland Medical Center, Baltimore, MD; (3)University of ColoradoSchool of Pharmacy, Aurora, CO PURPOSE: Accreditation Council for Pharmacy Education Standardsstate that pharmacy practice faculty should have or be workingtowards credentials related to their area of practice/expertise,including certification through the Board of Pharmacy Specialties(BPS). This study was conducted to determine the motivators andbarriers to board certification among pharmacy practice faculty. METHODS: Pharmacy practice faculty identified through theAmerican Association of Colleges of Pharmacy membership directorywere randomized in blocks based on faculty rank to receive aninvitation to complete an online survey regarding board certification. RESULTS: Of 900 faculty invited, 322 completed the survey(response rate 36%); of these, 308 considered themselves pharmacy

practice faculty and were included in the analysis. Current BPScertification was reported by 163 respondents (52.9%). Fourteen(4.5%) were previously certified. Among all survey respondents, themost common perceived reason why pharmacy practice facultybecome board certified is the desire to be recognized as an expert inthe field (71.5%) followed by personal growth (38.1%). In contrast,among those who are currently board certified, the most commonstated reason for seeking board certification was personal growth(60.5%, p<0.05) versus recognition as an expert (53.1%). Thosepreviously certified cited no perceived benefit as the most commonreason for not re-certifying (71.4%). Amongst those never boardcertified, no perceived need (52.0%) and no perceived benefit (44.8%)were the most common reasons for not becoming certified. A majorityof those never certified (68%) stated they would consider certificationif there was no associated cost and they were confident that theywould pass. CONCLUSION: Recognition by others and personal growth are themost common reasons why pharmacy practice faculty seek boardcertification. Although non-certified faculty indicated there is noperceived need or benefit, most would seek certification if it were freeand they were guaranteed to pass.

193E. Bromfenac Ophthalmic Solution for Treating the Signs ofDry Eye Disease. Simon P. Chandler, Ph.D.1, Sheri Rowen, M.D.2,Neal A. Sher, M.D.3, James A. Gow, M.D.1, Timothy R. McNamara,Pharm.D.1; (1)ISTA Pharmaceuticals, Inc., Irvine, CA; (2)MercyMedical Center, Baltimore, MD; (3)Eye Care Associates, Minneapolis,MN PURPOSE: To evaluate the efficacy of bromfenac ophthalmicsolution (bromfenac) using lissamine green staining in subjects withDry Eye Disease (DED). METHODS: On Day –14 and Day 0, subjects were diagnosed withmild or moderate DED with a mean National Eye Institute lissaminegreen staining grade of ≥1 in the same eye, with a minimum of 1/6regions graded ≥ 2 in the same eye. The same region must haveretained that grade on Days -14 and 0 in the same eye. During the 14screening days, eligible subjects received only Refresh Plus® eyedrops OU qid. From Day 0 - 42, subjects dosed bromfenac OU bid andRefresh Plus prn (≤qid). Subjects returned on Days 14±2, 28±2, and42±2 for safety and efficacy assessments. During a 10-day follow-up,Refresh Plus was dosed prn (≤qid), followed by a visit on Day 52±4. RESULTS: A total of 38 subjects were enrolled and analyzed forsafety, 38 were analyzed for efficacy in ITT population, and 31subjects were analyzed for efficacy in PP population. There was asignificant improvement from baseline in the mean lissamine greenstaining at Day 42. Mean corneal staining also showed a significantimprovement from baseline. No deaths, SAEs, or discontinuations dueto AEs and 9 subjects (23.7%) experienced 18 AEs. Most AEs wereeither mild (6/9 subjects, 66.7%) or moderate (2/9 subjects, 22.2%);1/9 subjects (11.1%) had a severe AE (sinusitis) considered nottreatment related. Two subjects had AEs (eye discharge and eye pain)considered possibly related to treatment. One subject had a mild AE offoreign body sensation in eyes during the follow-up. Visual acuity andIOP had no significant changes from baseline. CONCLUSION: The efficacy of bromfenac for DED subjects wasrobust and consistent in showing improvement in signs of DED for 42days and 10 days follow-up when treatment was discontinued. Presented at 6th International Conference on the Tear Film & OcularSurface Basic Science and Clinical Relevance, Florence, Italy,September 22–25, 2010.

194E. Integrated phase 3 clinical trials of bromfenac sodiumophthalmic solution dosed once daily for ocular surgery. Simon P.Chandler, Ph.D.1, Bonnie A. Henderson, M.D.2, Johnny L. Gayton,M.D.3, James A. Gow, M.D.4, Timothy R. McNamara, Pharm.D.4;(1)ISTA Pharmaceuticals, Irvine, CA; (2)Boston Eye Surgery & LaserCenter, Boston, MA; (3)Eyesight Associates of Middle Georgia,Warner Robins, GA; (4)ISTA Pharmaceuticals, Inc., Irvine, CA PURPOSE: To evaluate the efficacy and safety of bromfenac dosedQD for ocular surgery. METHODS: Subjects were assigned to receive either bromfenac(n=584) or placebo (n=288) dosed QD. Dosing began 1 day beforecataract surgery and continued through post-surgery day 14. Primary


efficacy endpoint was ocular inflammation by day 15; secondaryefficacy endpoint was number of subjects pain-free at day 1. RESULTS: : Bromfenac was superior to placebo (P≤0.0001) inachieving the primary and the secondary efficacy endpoint. Comparedto placebo, bromfenac dosed QD had a lower overall incidence ofocular adverse events. CONCLUSION: Bromfenac sodium ophthalmic solution dosed QDis safe and effective for the treatment of inflammation and painassociated with ocular surgery. Presented at the 114th Annual Meeting of the American Academy ofOphthalmology and Joint Meeting of the Middle East Africa Councilof Ophthalmology, Chicago, IL, October 16–19, 2010.

195E. The ocular comfort of bepotastine besilate ophthalmicsolution 1.5% in a safety clinical trial. Jon I. Williams, Ph.D.1,Stacey Ackerman, M.D.2, Jung T. Dao, M.D.3, Tushina A. Reddy,M.D.4, Timothy R. McNamara, Pharm.D.1, James A. Gow, M.D.1;(1)ISTA Pharmaceuticals, Inc., Irvine, CA; (2)Philadelphia EyeAssociates, Philadelphia, PA; (3)Cornea Consultants of Arizona,Phoenix, AZ; (4)Shepherd Eye Center, Las Vegas, NV PURPOSE: To evaluate the ocular comfort of bepotastine besilateophthalmic solution 1.5%, a dual-acting histamine H1 receptorantagonist and mast cell stabilizer, after 6 weeks of twice dailyophthalmic dosing. METHODS: This was a multi-center, randomized, masked, placebo-controlled, parallel-group, 6-week safety clinical trial of bepotastinebesilate ophthalmic solution 1.5% and placebo with 861 healthypediatric and adult subjects evaluated at 4 study visits. At Visits 2 and3, subjects scored ocular comfort immediately and 5 minutes post-instillation with a 4�point grading scale (0=comfortable, 3=severelyuncomfortable), 0.5-unit increments permitted. A clinically significantdifference in group mean comfort scores was >1.0 unit. RESULTS: Bepotastine besilate ophthalmic solution 1.5% subjectsshowed no statistically or clinically significant differences in ocularcomfort compared to placebo at any study visit when evaluated. Nobepotastine-related early withdrawals were due to ocular discomfort orsevere adverse events. CONCLUSION: Bepotastine besilate ophthalmic solution 1.5% wascomfortable with no significant differences compared to placebo. Presented at the 88th Annual Meeting of The American Academy ofOptometry,San Francisco, CA, November 17–20, 2010.

196E. Bepotastine besilate ophthalmic solution 1.5% rapidlydemonstrated near clearance of ocular itch in the conjunctivalallergen challenge model of allergic conjunctivitis. Julie C. Clark,M.D.1, Gordon L. Schooley, Ph.D.2, Jon I. Williams, Ph.D.1, James A.Gow, M.D.1, Timothy R. McNamara, Pharm.D.1; (1)ISTAPharmaceuticals, Inc., Irvine, CA; (2)Advanced Analytics andInformatics, LLC, Rancho Santa Fe, CA PURPOSE: To assess the efficacy of bepotastine besilate ophthalmicsolution (BBOS) 1.5% compared with placebo in near clearance ofocular itch using the conjunctival allergen challenge (CAC) model ofallergic conjunctivitis at an onset of action CAC test. METHODS: Two multicenter, double-masked, randomized, placebocontrolled, 7 week clinical trials using the CAC model of allergicconjunctivitis. Eligible subjects were assigned randomly to eitherBBOS 1.5% (n=156 eyes) or placebo (n=158 eyes). Ocular itchingwas graded on a 0-4 unit scale and 0.5 unit increments were allowed.All patients had to achieve a score ≥2 to qualify for randomization.More severely allergic subjects were those defined as those reporting ascore of 3 or greater in any eye at any time point during screening(BBOS 1.5% n=118 eyes, placebo n=108 eyes). Near clearance ofitching was determined as a grade of 0 (no itch) or 0.5 units(intermittent itch sensation without rubbing) at a majority ofobservation time points (i.e., 3, 5 and 7 minutes following an allergenchallenge) for a CAC test at 15 minutes after application of BBOS1.5% or placebo bilaterally. RESULTS: When measured at 3 minutes post-challenge, 75.0%(117/156) of subjects receiving BBOS 1.5% reported near clearance ofocular itch compared to 18.4% (29/158) of subjects receiving placebo.In more severely allergic subjects, the results were essentially thesame: BBOS 1.5% provided near clearance in 75.4% (89/118) of eyescompared to 17.6% (19/108) with placebo (P≤0.001).

CONCLUSION: BBOS 1.5% was substantially superior to placebo inproviding rapid and substantial relief of ocular itch, even in subjectswith more severe itching symptoms at screening. Presented at the 27th Annual Aspen Allergy Conference, Aspen, CO,July 27-31, 2010.

197E. Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%improves reflective ocular itching scores in a placebo-controllednatural exposure study of subjects with a demonstrated history ofseasonal allergic rhinoconjunctivitis (SAR). Jon I. Williams, Ph.D.1,Gary D. Berman, M.D.2, Ronald H. Saff, M.D.3, Allan Stillerman,M.D.4, James A. Gow, M.D.1, Timothy R. McNamara, Pharm.D.1;(1)ISTA Pharmaceuticals, Inc., Irvine, CA; (2)Allergy & AsthmaSpecialists, Minneapolis, MN; (3)Allergy & Asthma DiagnosticTreatment Center, PA, Tallahassee, FL; (4)Allergy & AsthmaSpecialists, PA, Minneapolis, MN PURPOSE: To establish the degree of ocular symptom improvementin a randomized, double-masked, placebo-controlled clinical study forsubjects with active rhinoconjunctivitis and a history of SAR in a 2-week natural exposure study following treatment with Bepreve® 1.5%twice daily. METHODS: Eligible subjects had to display evidence of activeocular and nasal allergic symptoms in order to be enrolled. Followingrandomization, 245 subjects at 12 clinical sites were assigned toplacebo or Bepreve 1.5% eyedrops and self-dosed twice daily (AMand PM) during active allergy season for 14 days. Among efficacyendpoints, reflective ocular itching symptoms were each graded bysubjects on a 0-3 unit scale (0 = none, 1 = mild symptoms, 2 =moderate symptoms, 3 = severe symptoms). RESULTS: Statistically significant reductions were seen in reflectivemean ocular itching scores for Bepreve 1.5% (N = 109) compared toplacebo (N = 108) in the Per Protocol population. Reduction inreflective ocular symptom scores was significantly better withBepreve 1.5% by ANCOVA analysis over the 2-week treatment period(P=0.025) and was evident within about 6 days of subject enrollment.Once significance was achieved for the ocular itching endpoint, itgenerally persisted through the end of the 2-week study period. Ratingof a beneficial global therapeutic response at the end of the treatmentperiod by study investigators was statistically superior (P=0.024) forBepreve 1.5% treatment compared to placebo. CONCLUSION: Bepreve 1.5% reduced reflective ocular itchingsymptom scores when compared to placebo in a 2-week naturalexposure study, achieving statistical significance for reduced ocularitching that was independently supported by determination of anobjective clinical response as judged by study investigators. Presented at the 83rd Annual Meeting of The Association for Researchin Vision and Ophthalmology, Inc., Ft. Lauderdale, FL, May 1–5,2011.

Pain Management/Analgesia

198. Bupivacaine extended release liposome injection(DepoFoam® bupivacaine) vs. bupivacaine HCl: A meta-analysisof multimodal trials of doses up to and including 300 mg. JosephDasta, M.S.1, Sonia Ramamoorthy, M.D.2, Gary Patou, M.D.3,Raymond Sinatra, M.D., Ph.D.4; (1)The University of Texas Collegeof Pharmacy, Austin, TX; (2)University of California at San Diego,San Diego, CA; (3)Pacira Pharmaceuticals, Parsippany, NJ; (4)Yale-New Haven Hospital, New Haven, CT PURPOSE: bupivacaine (DB) is an investigational formulation ofbupivacaine which allows for release over 72 hours. Studiescomparing the use of DB at doses up to 300 mg bupivacaine at dosesup to 200 mg were evaluated for several key endpoints. METHODS: Five active-control, double-blind, randomized, parallel-group trials in > 700 patients receiving doses up to and including 300mg were reviewed. All studies had a multi-modal setting (scheduledNSAID and/or acetaminophen plus rescue opioids as needed).Surgical models included , total knee , and hernia repair. Endpointsincluded the area under the curve (AUC) analysis through 72 hours ofthe numeric rating scale scores for pain, the median time to first opioid(TTFO) , the total amount of morphine equivalents consumed over 72hours (adjusted geometric mean), and the mean number of opioid-related adverse events (ORAE) per patient.

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RESULTS: Results demonstrated that DB was statistically superiorto bupivacaine

DB Bupivacaine(75–300 mg) HCl (75-200 mg) p-value

AUC 0–72 hr 315 427 p<0.0001 Median TTFO 9.9 hours 2.7 hours p<0.0001 Morphine 7.9 mg 15.8 mg p<0.0001 per pt 0.25 0.46 p<0.0001The adverse event profiles of the compounds were comparable; themost common treatment emergent adverse events reported across theentirety of the DB clinical program were nausea, constipation, andvomiting. CONCLUSIONS: DB appears to offer clinically meaningfuladvantages over bupivacaine in multi-modal trials for postsurgicalanalgesia.

199. Off-label, low-dose ketamine as an effective adjunctivetherapy for postoperative analgesia. Colleen M. Culley, Pharm.D.,BCPS1, Susan J. Skledar, B.S., M.P.H.1, Tara Pummer, Pharm.D.1, LoisPizzi, BSN, RN-BC2; (1)University of Pittsburgh School of Pharmacy,Department of Pharmacy and Therapeutics, Pittsburgh, PA;(2)University of Pittsburgh Medical Center Shadyside Campus,Inpatient Pain Management Coordinator, Pittsburgh, PA PURPOSE: Evaluate the safety and effectiveness of ketamine, anFDA-approved anesthetic agent, administered off-label in sub-anesthetic doses as an adjuvant analgesic, in terms of dosing, opioidconsumption, pain scores, and adverse events. Additionally,compliance with process measures such as use of electronic care set,proper labeling, pump administration, and specialist prescribing wasassessed. METHODS: A prospective evaluation was conducted for the patientsin the initial pilot of postoperative ketamine at two institutions in ourhealth system between May 14 and Sept 1, 2011. Ketamine wasadministered via continuous infusion through a secure patient-controlled analgesia (PCA) device, to patients already receiving PCAopioid and peripheral nerve block. Patient demographics, duration,dose, time to initiation of ketamine, pain scores and adverse eventswere collected. RESULTS: Twenty patients received ketamine in the pilot on generalpostoperative units. Median rate was 5 mg/hr (range 4–10) with amean dose of 100.4 mg/day. Mean time to initiation of ketamine aftersurgery end time was 22:16 hours (range 00:49–76:18) and meanduration of 51:23 hours (range 6:09–97:45). Mean PCA opioid doseper day was 14.2 mg pre-, 21.9 mg during and 17.9 mg post-ketamine.Pain score was significantly improved from median 7 initial to 3.5 atketamine infusion end (p<0.0001). Adverse events included urinaryretention (n = 1) and hallucinations (n = 2). There was 100%compliance with involvement of pain service specialists, use ofelectronic order set, proper PCA cartridge labeling, pumpadministration and nursing verification of competency. CONCLUSION: Sub-anesthetic doses of ketamine were effective indecreasing pain scores for postoperative patients in conjunction withopioids and peripheral nerve blocks. Ketamine was able to beadministered safely and met regulatory requirements leading toapproval for expansion of use. The protocol was changed to include anautomatic 48-hour stop on ketamine orders based on use.

200. DepoFoam® Bupivacaine (DB; EXPAREL™; BupivacaineExtended Release Multivesicular Liposome Injection) exhibitspharmacokinetic properties consistent with sustained releasecharacteristics. Deedee Hu, Pharm.D.1, Erol Onel, M.D.2, Neil K.Singla, M.D.3, Lakshmanasamy Somasundaram, M.D.4, Jeff Gadsden,M.D.4, William G. Kramer, Ph.D.5, Admir Hadzic, M.D., Ph.D.1;(1)Memorial Hermann Memorial City Medical Center, Houston, TX;(2)Pacira Pharmaceuticals, Inc., Ridgefield, CT; (3)Lotus ClinicalResearch, Inc., Pasadena, CA; (4)St. Luke’s Roosevelt Hospital, NewYork, NY; (5)Kramer Consulting LLC, North Potomac, MD PURPOSE: Liposomal drug containing formulations are designed toprovide slow release of drug over an extended period of time, thusextending duration while diminishing high plasma levels. Weconducted a cross-study analysis of the pharmacokinetic properties ofDB, an extended release multivesicular liposomal formulation ofbupivacaine in DepoFoam, given as a single injection.

METHODS: Pooled data from 446 individuals (age 18–85; 63%male) from eleven Phase 1–3 studies who received either DB orbupivacaine HCl were analyzed for pharmacokinetic parametersincluding Tmax, t1/2, and Cmax. Routes of administration includedwound infiltration, subcutaneous, epidural, and nerve block. Surgicalmodels included hemorrhoidectomy, herniorraphy, bunionectomy, andtotal knee arthroplasty. Doses ranged from 75mg-750mg. RESULTS: DB demonstrated bimodal peak concentrations at 0.25–2hours (likely due to the small amount of extraliposomal bupivacainepresent in the formulation) and at 12–24 hours after injection(resulting from the slow and prolonged release of bupivacaine fromthe DepoFoam). In contrast, bupivacaine HCl peaked once at 0.25–2hours with a rapid decline towards zero. After wound infiltration, DBexhibited a t1/2 of 34.1 hours and a highest mean plasma Cmax of 935ng/ml (2–4 fold below bupivacaine’s minimal toxicity thresholds),obtained after local administration of 600 mg DB. CONCLUSION: DepoFoam bupivacaine exhibited pharmacokineticproperties consistent with a sustained release formulation after a singleinjection. Plasma concentration remained well below bupivacaine’sreported toxic levels, even with doses of DB up to 600 mg.

201E. A post-hoc pooled data analysis to evaluate thegastrointestinal tolerability profile of tapentadol extended release(ER) versus oxycodone controlled release (CR) in patients ≥75years of age. David Biondi, D.O.1, Jim Xiang, Ph.D.1, MilaEtropolski, M.D.2, Bruce Moskovitz, M.D.1; (1)Ortho-McNeil JanssenScientific Affairs, LLC, Raritan, NJ; (2)Johnson & JohnsonPharmaceutical Research & Development, L.L.C., Titusville, NJ PURPOSE: To evaluate analgesic efficacy and tolerability oftapentadol ER (100-250 mg bid) versus oxycodone HCl CR (20–50mg bid) in patients ≥75 years of age. METHODS: This post-hoc analysis used pooled data from 3similarly-designed 15-week, randomized, double-blind, placebo- andactive-controlled, phase 3 studies of tapentadol ER for moderate-to-severe chronic osteoarthritis knee (NCT00421928, NCT00486811) orlow back (NCT00449176) pain. Analgesic efficacy was determined bythe change in pain intensity (11-point numerical rating scale). Times toinitial onset of gastrointestinal TEAEs and time to studydiscontinuation due to these TEAEs were estimated using Kaplan-Meier plots. RESULTS: Similar numbers of subjects were in each treatment arm(tapentadol ER, n=72; oxycodone CR, n=78). No significant between-treatment difference in the least-squares mean (SEM) change in painintensity from baseline to Week 15 was observed (tapentadol ER,−3.66[0.44]; oxycodone CR,−4.02[0.54];P=0.604). Significantlylower percentages of patients who received tapentadol ER versusoxycodone CR reported gastrointestinal TEAEs (51.4% vs71.8%;P=0.0119) and study discontinuations due to gastrointestinalTEAEs (16.7% vs 42.3%;P=0.0007). Times to initial onsets of nausea,vomiting, and constipation and times to study discontinuation due tonausea and vomiting occurred later with tapentadol ER versusoxycodone CR (all P≤0.0388; time to discontinuation due toconstipation, P=0.4685). Patients experienced the following commonopioid-related gastrointestinal TEAEs for lower mean percentages ofstudy days with tapentadol ER versus oxycodone CR, respectively:nausea, 10.2% versus 20.2%, P=0.0621; vomiting, 1.6% versus 9.1%,P=0.0008; constipation, 12.0% versus 24.8%, P=0.1144. Severityratings of the common opioid-related gastrointestinal TEAEs (nausea,vomiting, constipation, and nausea and/or vomiting) were generallylower with tapentadol ER versus oxycodone CR. CONCLUSION: Tapentadol ER (100–250 mg bid) was associatedwith comparable analgesia and better gastrointestinal tolerability thanoxycodone HCl CR (20–50 mg bid), including lower incidences ofgastrointestinal TEAEs and study discontinuation due togastrointestinal TEAEs, in patients ≥75 years of age. Published in Biondi D, Xiang J, Etropolski M, Moskovitz B. JPain.2011;12(4)Suppl 1:P56[Abstract 320].

202E. A post-hoc pooled data analysis to evaluate blood pressure(BP) and heart rate (HR) measurements in patients with a currentor prior history of hypertension who received tapentadol ER,oxycodone CR, or placebo in chronic pain studies. David Biondi,D.O.1, Jim Xiang, Ph.D.1, Mila Etropolski, M.D.2, Bruce Moskovitz,


M.D.1; (1)Ortho-McNeil Janssen Scientific Affairs, LLC, Raritan, NJ;(2)Johnson & Johnson Pharmaceutical Research & Development,L.L.C., Titusville, NJ PURPOSE: Tapentadol is a centrally-acting analgesic with µ-opioidreceptor agonist and norepinephrine reuptake inhibitor activity. Ananalysis of pooled data from 3 similarly-designed 15-week,randomized, double-blind, placebo- and active-controlled, phase 3studies of tapentadol ER for moderate-to-severe chronic osteoarthritisknee pain (NCT00421928, NCT00486811) or low back pain(NCT00449176) found no clinically relevant changes in mean BP orHR measurements with placebo (n=946), tapentadol ER (100–250mgbid; n=920), or oxycodone HCl CR (20–50mg bid; n=831). METHODS: This post-hoc analysis of those pooled data evaluatedsystolic BP (SBP), diastolic BP (DBP), and HR in 2 cohorts—patientswith a medical history of hypertension and patients with aconcomitant anti-hypertensive medication. RESULTS: In patients with a history of hypertension, the leastsquares mean (LSM [SE]) change from baseline to endpoint in BP andHR with placebo (n=459), tapentadol ER (n=462), and oxycodone CR(n=413), respectively, was SBP, -2.4 (0.64), -2.7 (0.64), and -3.7(0.67) mmHg; DBP, -1.0 (0.39), -1.3 (0.39), and -2.3 (0.41) mmHg;HR, -0.7 (0.44), 0.2 (0.43), and -0.9 (0.45) beats-per-minute (bpm). Inpatients with a concomitant anti-hypertensive medication, the LSM(SE) change from baseline to endpoint in BP and HR with placebo(n=429), tapentadol ER (n=434), and oxycodone CR (n=387),respectively, was SBP, −1.8 (0.66), -3.3 (0.65), and -3.7 (0.69) mmHg;DBP, -0.7 (0.40), -1.4 (0.40), and -2.3 (0.42) mmHg; HR, -0.6 (0.45),0.1 (0.44), and -0.7 (0.47) bpm. There were no significant differencesbetween tapentadol ER and placebo or oxycodone CR in the LSMchanges from baseline to endpoint in SBP, DBP, or HR.CONCLUSION: These results showed no clinically relevant changesin BP or HR with tapentadol ER (100-250mg bid) or oxycodone HClCR (20–50 mg bid) and suggest that tapentadol ER is a reasonabletreatment option for chronic pain management in patients withhypertension.Published in Biondi D, Xiang J, Etropolski M, Moskovitz B. JPain.2011;12(4)Suppl 1:P55[Abstract 319].

203. Pharmacists perceptions and knowledge regarding opioidrisk evaluation and mitigation strategies (REMS) in communityand ambulatory practice. Karen Marlowe, Pharm.D., BCPS,DAAPM, Emily McCoy, Pharm.D.; Auburn University/Univ. of S. AL,Fairhope, AL PURPOSE: The purpose of the study is to assess ambulatory carepharmacist’s perceptions and knowledge regarding opioid riskevaluation and mitigation strategies in community and ambulatorypractice. METHODS: This study was approved by the Institutional ReviewBoard at Auburn University. A link to a 40 question survey wasdistributed via email to pharmacists who subscribe to an ambulatorycare list-serve. The survey was completed anonymously using theQualitrics® survey software. The survey asked demographic questionsregarding educational background, length of time in practice, andamount of practice devoted to pain management, as well asapproximately 4 questions concerning the pharmacists’ currentknowledge of REMS for opioid use, 5 questions concerning thepharmacists’ methods for implementing REMS in their practice sites,and 20 questions concerning the pharmacists’ opinion of REMS.Prevalence of individual practice strategies including treatmentagreements, opioid informed consents, treatment monitoring with drugtesting, and patient educations strategies will be assessed. RESULTS: 79 pharmacists responded to the survey, with 69completing all questions. 67% of the respondents had heard of REMSfor opioids, and only 19% had formal policies in place to addressREMS for opioids when this survey was done in March 2011. Themost popular tools in use for increasing patient adherence to therapywere treatment agreements (84%) and urine drug screens (51%).Approximately half of those surveyed did not feel opioid REMSwould improve the situation with opioid use in their clinic. CONCLUSION: Ambulatory care pharmacists are in a uniqueposition to care for patients in chronic pain and will be required toutilize mandated REMS procedures for opioids products. Currentknowledge and utilization of REMS appears to be an area for targeted

education.

204. Meta-analysis of the tolerability of tapentadol. Vanessa White,Pharm.D., Stephanie L. Ballard, Pharm.D.; Nova SoutheasternUniversity, Palm Beach Gardens, FL PURPOSE: Tapentadol is an oral analgesic which agonizes mu-opioid receptors and inhibits norepinephrine synaptic uptake. Ourobjective was to systematically identify and synthesize available dataon adverse events associated with use of the new analgesic tapentadolcompared with placebo and oxycodone. METHODS: We performed a database search for “tapentadol” inMedline, Embase, International Pharmaceutical Abstracts,ClinicalTrials.gov, and Google Scholar. Our search was augmented bycitation tracking and package insert information. Randomized,controlled trials evaluating the safety or tolerability of tapentadol inEnglish were included. Two independent investigators extracted studydata, which was pooled and analyzed using a Mantel-Haenszelrandom effects model. RESULTS: Ten studies met inclusion criteria, including 8randomized, placebo-controlled trials (n=3,800), and 8 papers with anoxycodone active control (n=5,310). Indications for pain controlincluded post-surgical and chronic pain due to osteoporosis anddiabetic peripheral neuropathy. Studies used total daily doses oftapentadol immediate release (IR) and extended release (ER) rangingfrom 25–600 mg and 200–600 mg, respectively, as well as oxycodoneIR and CR, dosed from 20–90 mg and 40–100 mg daily, respectively.Compared to placebo, patients receiving tapentadol were found to bestatistically significantly more likely to experience nausea, dizziness,somnolence, constipation, pruritis, fatigue, vomiting, hyperhidrosisand dry mouth. The relative risk (RR) for any adverse event wassignificantly lower with tapentadol than oxycodone (RR 0.78; 95%confidence interval 0.68-0.87). When compared to oxycodone,patients receiving tapentadol were more likely to experience drymouth (RR 1.6; 1.31–2.63), and less likely to report nausea (RR 0.62;0.56–0.69), dizziness (RR 0.86; 0.75–0.96), vomiting (RR 0.40;0.26–0.61), pruritis (RR 0.50; 0.39–0.64), and constipation (RR 0.47;0.56–0.69). CONCLUSION: Treatment of moderate to severe pain withtapentadol was associated with fewer adverse events than oxycodonetherapy, with the exception of dry mouth.

Pediatrics

205. Pharmacokinetics of mycophenolic acid and glucuronidatedmetabolites following mycophenolate mofetil and mycophenolatesodium dosing in pediatric renal transplant recipients. Tony K.L.Kiang, Ph.D.1, Mina Matsuda-Abedini, MDCM2, Mary H.H. Ensom,Pharm.D.1; (1)Faculty of Pharmaceutical Sciences, The University ofBritish Columbia & Child and Family Research Institute, Vancouver,BC, Canada; (2)Department of Pediatrics, Division of Nephrology, BCChildren’s Hospital, Vancouver, BC, Canada PURPOSE: To characterize and compare the pharmacokinetics (PK)of mycophenolic acid (MPA) and its glucuronidated metabolites,MPAG (phenolic-glucuronide) and AcMPAG (acyl-glucuronide),following steady-state (equimolar) doses of mycophenolate mofetil(MMF) and enteric-coated mycophenolate sodium (EC-MPS) in stablepediatric renal transplant recipients. METHODS: Following written informed consent and uponadministration of a steady-state morning MMF dose, blood sampleswere collected at pre-dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and8 hours. The sampling schedule was repeated in 3 months, afterpatients were converted to EC-MPS. Total MPA, MPAG, andAcMPAG concentrations were measured by a validated high-performance liquid chromatography-ultraviolet method and PKparameters calculated by non-compartmental analysis. RESULTS: Patients were: 2 males and 2 females,(median[interquartile range]) 33.0 [3.2–65.5] month post-transplant,age 12.0 [9.8–14.3] yrs and weight 38.4 [28.9–50.6] kg, with serumcreatinines 87.5 [69.0–129.8] (MMF visit) and 109.0 [89.0–222.5]μmol/L (EC-MPS visit). All were on prednisone and tacrolimus. Dose-normalized PK parameters of MPA from steady-state doses of MMFand EC-MPS were: (median[interquartile range]) area-under-the-curve(AUC) 19.9 [15.9–32.1] vs. 21.5 [12.2-32.3] μg×h/mL/g; maximal

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concentration (Cmax) 12.5[5.8–22.2] vs. 9.5[7.8–9.7] μg/mL/g; andminimum concentration (Cmin) 0.7 [0.4–1.2] vs.0.8 [0.5–1.4] μg/mL/g(p>0.05 for all MMF vs. EC-MPS comparisons). The AUCs of MPAG(217.6 [157.8–368.1] vs. 265.6 [194.3–367.0] μg×h/mL/g; MMF vs.EC-MPS) and AcMPAG (1.8 [0.9–3.5] vs. 1. 5[0.9–2.7] μg×h/mL/g);AUC-ratios of MPAG/MPA (14.5 [10.4–15.6] vs 12.6 [7.2–18.8]) andAcMPAG/MPA (0.1 [0.1–0.1] vs. 0.1 [0.0–0.1]) were also similarwhen comparing MMF and EC-MPS. CONCLUSION: Similar PK parameters of MPA and its metabolitesfollowing steady-state MMF and EC-MPS doses were observed in thispilot crossover study. This may be due to the small sample size and/orwide inter-individual variability (as has been observed in otherpopulations). These preliminary data suggest that equimolar doses ofMMF and EC-MPS yield comparable exposure to MPA and itsglucuronidated metabolites in pediatric renal transplant recipients andwarrant confirmation in a larger population.

206. Peroxisome proliferator-activated receptor � activity isaltered by omega-3 polyunsaturated long-chain fatty acids in acholestatic liver disease model. Emma M. Tillman, Pharm.D.,Richard A. Helms, Pharm.D., Dennis D. Black, M.D.; University ofTennessee Health Science Center, Memphis, TN PURPOSE: Parenteral nutrition (PN)-associated liver disease(PNALD) occurs in children receiving long-term PN. Studies havedemonstrated improvement of PNALD with omega-3 long-chainpolyunsaturated fatty acids (w3PUFA) containing eicosapentaenoicacid (EPA) and docosahexaenoic acid (DHA), which are ligands forthe nuclear receptor transcription factor, peroxisome proliferator-activated receptor-� (PPARa), that has anti-inflammatory and anti-apoptotic properties. Studies in cystic fibrosis transmembraneconductance regulator (CFTR) knockout mice with bile duct injuryshowed a defect in PPARa expression, which was reversed by DHAtreatment (Pall H et al.J Pediatr Gastroenterol Nutr.2006;42:275–81). The aim of this study was to determine if PPARαactivity is altered with w3PUFA treatment in a model of PNALD. METHODS: Activation of PPARa in HepG2 cells was evaluated byisolation of nuclear protein after 4-hr treatment with the lipophilic bileacid, chenodeoxycholic acid (CDCA) 200μM ± w3PUFA (EPA5μM+DHA 5μM). PPARa activity was measured by assessingtranscription factor activity in a non-radioactive, sensitive ELISAmethod for detecting PPARa DNA binding activity in nuclear extracts. RESULTS: Treatment of HepG2 cells with w3PUFA alone resulted inPPARa activity equal to that observed with recombinant PPARa andDNA binding of PPARa was decreased by 70% in the presence ofCDCA (p<0.001). Treatment with CDCA and w3PUFA resulted in lessreduction of PPARa activity as compared to controls. Although thiswas not significantly different from that of CDCA alone, there was atrend to restoration of PPARα activity with the addition of ω3PUFA. CONCLUSION: Activity of PPARα was reduced by treatment withlipophilic bile acid and increased in the presence of w3PUFA. Theseresults are similar to studies in CFTR knockout mice and suggest thatPPARa activation may be a promising mechanism by which w3PUFAattenuate the bile acid-induced hepatocellular injury that occurs incholestasis, such as that seen in PNALD.

207. Gentamicin pharmacokinetics in neonates undergoingtherapeutic hypothermia. Liana Mark, Pharm.D.1, AddishiwotSolomon, Pharm.D.2, Frances J. Northington, M.D.3, Carlton K.K.Lee, Pharm.D., M.P.H.4; (1)The Johns Hopkins Hospital, Baltimore,MD; (2)University of Maryland School of Pharmacy, Baltimore, MD;(3)Department of Pediatrics, Neuro-Intensive Care Nursery, JohnsHopkins University, Baltimore, MD; (4)Department of Pediatrics,Johns Hopkins University & Department of Pharmacy, The JohnsHopkins Hospital, Baltimore, MD PURPOSE: This study evaluated the effects of whole bodytherapeutic hypothermia in newborns with hypoxic ischemicencephalopathy (HIE) on gentamicin pharmacokinetics. These resultswere compared to newborns with HIE receiving gentamicin whoeligible for, but did not receive, therapeutic hypothermia. METHODS: Subjects with HIE who received therapeutichypothermia were identified via a database maintained by The JohnsHopkins Hospital Neonatal Intensive Care Unit from January 1, 2007through July 31, 2010. Eligible neonates were those who received

intravenous gentamicin during the period of cooling and whose serumsampling occurred around or after the third continuous dose.Individual pharmacokinetic parameters were characterized accordingto standard first order pharmacokinetic equations and compared to anage-matched control group consisting of neonates with HIE whoreceived gentamicin antibiotic therapy and who were not cooled butwho met criteria for therapeutic hypothermia. Control subjects wereidentified via an International Classification of Diseases, 9th Revision(ICD-9) code for HIE from a hospital billing database. RESULTS: Sixteen neonates who received therapeutic hypothermiaand seven neonates who did not receive therapeutic hypothermia metour inclusion criteria. Significant differences in gentamicinpharmacokinetics were noted between the therapeutic hypothermiagroup and the comparator group in elimination rate constant (0.08 +0.02 vs. 0.11 + 0.03 h-1 , p<0.01), elimination half-life (9.16 + 2.08vs. 6.56 + 1.81 h, p<0.01), and clearance (0.04 + 0.01 vs. 0.05 + 0.01L/h, p<0.01), respectively. Neonates who received therapeutichypothermia had higher trough serum concentrations (1.68 + 0.69 vs.0.77 + 0.53, p<0.01). No difference was seen in volume of distributionor peak concentrations between the groups. CONCLUSION: Therapeutic hypothermia is associated withalterations in gentamicin pharmacokinetics, reducing gentamicinclearance by 25.5% in neonates with HIE, which may result inincreased trough serum concentrations.

208. Comparison of pediatric versus adult safety studies for drugapproval of antiviral and antipsychotic agents. Gilbert J. Burckart,Pharm.D.1, Theresa Yoon, B.S.2, Xiaomei Liu, M.S.,3, Allen Rudman,Ph.D.4; (1)Office of Clinical Pharmacology, CDER, FDA, SilverSpring, MD; (2)Fletcher Allen Health Care, Burlington, VT;(3)University of Minnesota School of Pharmacy, Duluth, MN; (4)U.S.Food and Drug Administration, CDER, Office of ClinicalPharmacology, Silver Spring, MD PURPOSE: This study was conducted to determine the comparabilityof safety studies conducted in pediatric and adult patients. Theantiviral and antipsychotic agents were chosen for this review. METHODS: A retrospective investigation of adverse events (AEs) inclinical studies submitted to the FDA was performed in the twotherapeutic areas. Seventeen antiviral drugs and eleven antipsychoticdrugs were reviewed, and only drugs in which both pediatric and adultclinical data were available were evaluated for these studies. All of thestudies were clinical trials conducted for submission to the FDA fordrug approval. The AE and safety terminology was based onnomenclature described in the specific submission and were notfurther standardized. RESULTS: Eleven of the 17 antiviral drugs had both pediatric andadult safety information available. For the 11 antiviral agents, 1534pediatric patients were included in the safety studies versus 4188 adultpatients. Only 3 of the 11 antipsychotic agents had both pediatric andadult safety information. Those 3 safety studies were conducted in1045 pediatric patients and 2831 adult patients. Complete agreementof the AE profile between the pediatric and adult patients was foundfor 0/11 antiviral agents and 0/3 antipsychotic agents. Differencesbetween pediatric and adult studies were observed in both incidence ofan AE and the type of AE, and in AE terminology. CONCLUSION: Safety studies in pediatric patients are conducted insmaller patient populations than adult safety studies for drug approval.The AE profiles for adult versus pediatric patients were very differentfor these two drug classes. The implications of these findings are that:(1) novel methods of conducting pediatric safety studies for new drugsshould be sought, and (2) consistent methods of classifying andidentifying AEs should be applied whenever possible in pediatric andadult safety studies.

209E. An NIH sponsored pharmacist curriculum on interventionsfor Sudden Infant Death Syndrome (SIDS) risk reduction. HananKallash, M.S.; Eunice Kennedy Shriver National Institute of ChildHealth and Development, Baltimore, MD PURPOSE: Research indicates that pharmacists can benefit from acontinuing education program on Sudden Infant Death Syndrome asthe role of the pharmacist continues to expand. Alldrege and Koda-Kimble published an opinion piece in the American Journal ofPharmaceutical Education which stated that pharmacist roles of


prescribing, educating and monitoring patients leads to jobsatisfaction. They recommend pharmacists take a larger role in patientcare(Douglas, 2007, Boardman et al 2005). Several studies indicatethat patients are willing and open to receiving information from theirpharmacists regarding issues related to health promotion(Chen 2000,Iverson 2001).Patients surveyed indicated that there was a positiveattitude towards expanding the pharmacist role to include healthyliving advice, health screening activity and general practitionersupport. This seems to be especially pertinent for mothers of youngchildren according to a study conducted by Hodgson and Wong whichfound that 61 percent of the mothers they surveyed were visiting thepharmacist at least once a month, 22 percent stated they receivedadvice and of that 87 percent reported the suggestions to be helpful orvery helpful. METHODS: A CE program was created in partnership with 6national pharmacist groups. Focus groups were conducted in 3demographically diverse states, The CE is in Active Learning Toolformat with cases and problem solving on caregiver/parent culturallycompetent education. Pre and post test are administered to measureknowledge base. Letters were sent to pharmacy associations andspecific SOP to recruit participants. RESULTS: 360 Pharmacists and 118 students have completed theprogram with average increase in assessment scores of 26–34%. CONCLUSION: This program significantly increases pharmacistsability to: Define SIDS, list critical SIDS risk-reduction messages forparents/caregivers, list four barriers to back sleeping forparents/caregivers, and increase pharmacists competency as educatorsto parents/caregivers and peers about SIDS in a culturally appropriatemanner. Presented at American Pharmacy Association Annual conference,Washington DC, March 25–29, 2011.

210. Evaluation of vancomycin use for pediatric Staphylococcalinfections. Rebecca F. Chhim, Pharm.D.1, Sandra Arnold, M.D.,FRCPC1, Kelley Lee, Pharm.D., BCPS2; (1)University of Tennesseeand Le Bonheur Children’s Hospital, Memphis, TN; (2)Le BonheurChildren’s Hospital and University of Tennessee, Memphis, TN PURPOSE: Due to concern related to increasing vancomycinminimal inhibitory concentrations (MIC) for methicillin-resistantStaphylococcus aureus (MRSA), recent guidelines have recommendedmore aggressive dosing (60 mg/kg/day) and higher troughconcentrations (15 – 20 mcg/ml) than traditionally used in pediatrics.The objective of this study was to evaluate our dose/troughrelationship and determine if treatment failures were occurring withtraditional dosing in pediatric patients with invasive staphylococcalinfections. METHODS: This was a retrospective cohort study including patientsreceiving vancomycin for suspected invasive gram-positive infection.Patients were excluded for age less than two months, baseline renaldysfunction, non-weight based dosing, treatment for skin or soft tissueinfection, no trough concentration, or inappropriately drawn trough.Clinical outcomes were evaluated in patients who had positivecultures for S. aureus. MICs were measured using broth microdilution.Troughs ≥ 10 mcg/ml were considered therapeutic. RESULTS: Dose and trough correlations were evaluated in 254patients. Fifty-eight patients had a positive staphylococcus culture. Ofthose receiving 40 mg/kg/day for confirmed staphylococcal infection,26% had undetectable trough concentrations and 70% hadconcentrations < 10 µg/ml. In patients receiving 60 mg/kg/day, 42%had trough concentrations < 10 µg/ml. Only 5% of MRSA isolates hadMICs ≥ 2. By the end of treatment, 76% of patients with positivecultures were receiving 60 mg/kg/day or higher. In these patients, 12%had trough concentrations > 20 µg/ml. Treatment failure resulting in achange in antibiotics was only observed in one patient. CONCLUSION: Traditional vancomycin dosing regimens did notresult in recommended trough concentrations in the majority ofpatients. Dose escalation was performed to obtain therapeutic (≥ 10µg/mL) trough concentrations although treatment failure for invasivestaphylococcal infections was rare. Supratherapeutic concentrationswere not commonly observed with higher dosing. At least 60mg/kg/day appears to be necessary to routinely produce recommendedvancomycin trough concentrations in patients with invasive infections.

211. Characterization of cannabinoid usage in a pediatriconcology population. Joshua J. Elder, Pharm.D.1, Holly M.Knoderer, M.D.2; (1)Indiana University Health, Indianapolis, IN;(2)Indiana Univerisity School of Medicine, Indianapolis, IN PURPOSE: Chemotherapy-induced nausea and vomiting (CINV)remains an important side effect associated with the administration ofchemotherapy in pediatrics. The aim of this study is to retrospectivelystudy dronabinol use in an academic pediatric cancer center with theintent of characterizing its use and identifying trends such as age,gender, diagnosis, and chemotherapy that describe where dronabinolmay be best appropriate as an adjuvant antiemetic. METHODS: Patients receiving dronabinol at Riley Hospital forChildren between 2000 and 2010 were identified. Eligible patientswere those with malignancy ≤ 18 years old who received at least onedose of dronabinol for CINV during admission. The followingparameters were collected: demographics, chemotherapy regimen,dronabinol dosing and frequency, emetic events, repeat courses ofdronabinol, and outpatient prescriptions for dronabinol. RESULTS: The mean age was 13.9 years. Leukemia and sarcomaswere the most common diagnoses, comprising 36% of the populationrespectively. Ninety five percent of patients received moderate orhighly emetogenic chemotherapy. When examining dronabinol dosing,95% received lower doses than referenced guidelines, 55% receiveddronabinol as a scheduled medication, and 23% received dronabinol1–3 hours prior to chemotherapy. Overall, 60% of patients had adefined good response to dronabinol. Sixty five percent of patientsreceived repeat courses of dronabinol and 62% received outpatientprescriptions for dronabinol. CONCLUSIONS: Dronabinol appears to be a viable option as anadjuvant antiemetic in pediatric CINV, but a prospective trial usingpatients as their own controls would be appropriate to trulydronabinol’s place in therapy.

212. Comparison of single dose arginine hydrochloride to multipledoses of acetazolamide to correct metabolic alkalosis in pediatricpatients. Alex Oschman, Pharm.D., Daniel Heble Jr., Pharm.D., TracySandritter, Pharm.D.; Children’s Mercy Hospital, Kansas City, MO PURPOSE: To determine if a course of arginine hydrochloride oracetazolamide was more effective in correcting metabolic alkalosiswithin a 24-hour period in pediatric patients. METHODS: Institutional Review Board approval was obtained forthis retrospective comparative study. Inclusion criteria: PICU or NICUpatients who received a course of acetazolamide or argininehydrochloride (defined as 3–4 doses of acetazolamide or 66–100% ofthe full calculated dose of arginine hydrochloride) for metabolicalkalosis, and had a repeat metabolic panel 18–30 hours aftertreatment initiation. Exclusion criteria: Previous treatment with eitherdrug within 24 hours of the study period or a documented metabolicdisorder. Primary endpoints: Mean change in serum CO2 and Clconcentrations and percent achieving metabolic alkalosis correction(serum CO2 < 30 mmol/L and Cl- >96 mmol/L). A subgroup analysiswas conducted on patients who received concomitant therapy withacetazolamide and arginine. RESULTS: Forty-four patients met inclusion criteria; nine patientsreceived both agents concurrently and were evaluated as a subgroup.Treatment success was higher in the acetazolamide group (37% vs 6%,p=0.047). The acetazolamide and arginine groups had a similarcorrection of serum Cl- concentration (63% vs 31%, p=0.092) with theacetazolamide group experiencing a higher rate of serum CO2correction (42% vs 6%, p=0.002). Both groups had a similar increasein mean serum Cl- (5.7± 5.3 vs 5.1± 5.1 mmol/L, p=0.76). Meanserum CO2 (5.6±5.2 vs 3.7±5.7, mmol/L, p=0.30) decreased similarily.In the subgroup analysis, treatment success was equivalent betweenacetazolamide monotherapy and concomitant therapy (37% vs 44%,p=1.0). Arginine monotherapy was less successful than concomitanttherapy (6% vs 44%, p=0.040). CONCLUSION: A course of acetazolamide or argininehydrochloride appears to be safe and effective options for resolution ofmetabolic alkalosis in pediatric patients.

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Pharmacoeconomics/Outcomes

213E. Evaluation of the hospital resource utilization associatedwith tolvaptan usage among heart failure patients withhyponatremia from the Everest trial. Joseph Dasta, M.S., R.Ph.1,Jun Chiong, M.D., M.P.H.2, Sonnie Kim, Pharm.D.3, Jay Lin, Ph.D.4;(1)College of Pharmacy, The Ohio State University, Columbus, OH;(2)Advanced Heart Failure Program, Loma Linda University, LomaLinda, CA; (3)Otsuka America Pharmaceutical, Inc., Princeton, NJ;(4)Novosys Health, Flemington, NJ PURPOSE: Tolvaptan is an orally administered selective vasopressinV2-receptor antagonist for hyponatremia treatment. The Efficacy ofVasopressin Antagonism in Heart Failure Outcome Study withTolvaptan (EVEREST) trial showed that tolvaptan, combined withstandard therapy, improved many heart failure signs and symptomswithout serious adverse events. This study evaluated the hospitalresource utilization associated with tolvaptan usage among heartfailure (HF) patients with hyponatremia based on the EVEREST trial. METHODS: A cost offset model was constructed to evaluate theimpact of tolvaptan on hospital resource utilization among HFpatients. The Healthcare Cost and Utilization Project (HCUP) 2008Nationwide Inpatient Sample (NIS) database was used to estimatehospitalization length of stay (LOS) and hospital cost, for HF-associated diagnosis related group hospitalizations (DRG) of adultpatients (age ≥18 years). EVEREST trial data for patients withhyponatremia were used to estimate the reduction of LOS associatedwith tolvaptan vs. placebo. RESULTS: Among EVEREST trial HF patients with hyponatremia(<135 mEq/L), tolvaptan patients had a shorter hospitalization LOSthan placebo patients (9.72 vs. 11.44 days, respectively), with arelative LOS reduction of 15%. 933,189 HF-associated DRGhospitalizations were identified from the HCUP NIS database. Themean LOS was 4.8 days with mean total hospital costs of $7,545, andmean daily hospital costs of $1,562. Using an inpatient tolvaptantreatment duration of 3 days with a daily wholesale acquisition cost of$250, the cost offset model estimated a LOS reduction among US HFhospitalizations of 0.73 days with a hospital cost reduction averaging$1,134 per HF admission. The cost neutral breakeven mean durationof tolvaptan inpatient therapy is 4.54 days. CONCLUSION: Based on the EVEREST trial, tolvaptan isassociated with a shorter hospitalization LOS than placebo amonghyponatremic HF patients, resulting in an estimated mean hospitalcost reduction of $1,134 per admission in the US. Presented at Presented at International Society for Pharmaco-economics and Outcomes Research (ISPOR) 16th AnnualInternational Meeting, Baltimore, MD, USA, May 21–25, 2011.

214. The impact of possible undiagnosed heavy menstrualbleeding (HMB) on presenteeism and activities outside of work.Mark McCoy, Pharm.D., MBA1, Nathalie Horowicz-Mehler, M.S.,M.P.H.2, Amy W. Law, Pharm.D., MS1; (1)Bayer HealthCarePharmaceuticals, Wayne, NJ; (2)Quintiles, Hawthorne, NY PURPOSE: The study measured the impact of possible undiagnosedheavy menstrual bleeding on presenteeism and regular activities. METHODS: A sample of 122,525 US women ages 18–54 from anonline patient community were invited to complete a survey abouttheir menstrual bleeding. A subset of women with possibleundiagnosed or no HMB completed an additional questionnaire on thenumber of work hours missed due to menstrual bleeding (i.e.,absenteeism) and the impact of menstrual bleeding on productivitywhile working (i.e., presenteeism) or regular activities outside of workfrom the modified Work Productivity and Activity Impairment(mWPAI) questionnaire. Responses to the impact questions weremeasured with Likert scales ranging from 0 to 10. Chi-square and t-test were used to determine statistical significance. RESULTS: 2,062 (1.7%) women responded to the survey, of which251 women (163 possible undiagnosed HMB, 88 no HMB) whocompleted the mWPAI questionnaire. Compared to women with noHMB, the possible undiagnosed HMB group reported a significantlygreater impairment in regular activities (55% vs. 29%, p<0.0001) andpresenteeism (45% vs. 21%, p<0.0001) during their menstrual periods.No significant difference was found for absenteeism. CONCLUSION: In this limited sample, women with possible

undiagnosed HMB exhibited higher presenteeism and greaterimpairment in non-work activities than women with no HMB. Furtherresearch is needed to validate these results in a broader population andquantify the indirect costs associated with these effects.

mWPAI Results“Undiagnosed Difference

“no HMB” HMB” inMeasure Mean ± SD Mean ± SD ImpairmentWork Hours Missed 1.8 ± 5.9 (n=60) 3.4 ± 6.0 (n=95) 1.61 16%

Productivity Impairment

at Work (Presenteeism) 2.1 ± 2.4 (n=60) 4.5 ± 2.7 (n=95) 2.42 24%

Actvity Impairment 2.9 ± 2.7 (n=88) 5.5 ± 2.5 (n=163) 2.62 26% 1p=0.09; 2p<0.0001

215. Title: West Michigan Glycemic Collaborative (WMGC):Improving inpatient glycemic control and transition of carethrough interdisciplinary, inter-institutional collaboration. JodieL. Elder, Pharm.D., BCPS1, Larry Custer, R.Ph.2, Mary Wilson, NP,CDE3, Robert Rood, M.D.3, Adam Wolfe, D.O.2; (1)Ferris StateUniversity College of Pharmacy, Grand Rapids, MI; (2)Metro HealthHospital, Wyoming, MI; (3)St. Mary’s Health System, Grand Rapids,MI PURPOSE: Although there are some interactions between healthsystems in the state of Michigan, there has been no formal,independent forum for collaboration and the development of jointpatient care initiatives. In this report, we describe the implementationof diabetes collaborative between 3 competing hospitals in WestMichigan. The collaborative aspires to systematically improvemember hospitals patient outcomes and work toward consensualagreement as they focus on aspects of care having the greatestcollective impact. METHODS: The West Michigan Glycemic Collaborative wasestablished in 2008 and its members include Metro Health Hospital,Saint Mary’s Health Care. Representatives from each of the hospital’smedical and clinical staff including pharmacists, nurses and physiciansmeet monthly to discuss inpatient diabetes care initiatives andtransition of care. Joint leadership was established, with one the tri-chairs being a pharmacist. Glucometrics shared between institutionsincluded established measurements of hypoglycemia andhyperglycemia. RESULTS: Since the formation of the collaborative in 2008, the threeinstitutions eliminated sliding scale insulin and implemented basal-bolus protocols. A letter describing the purpose of the collaborativewas developed and sent to the physician community to improvephysician acceptance of protocols. Perio-operative glycemicmanagement protocols have been developed and implemented,resulting in reductions in hospital acquired infection and length ofstay. Improvements in outpatient and in-patient provider and patienteducation care have been seen at all three institutions. CONCLUSION: The West Michigan Glycemic collaborative hasdemonstrated benefits that include: increased patient safety,implementation of evidence-based guidelines and decreases indeviation from protocols. Each hospital and respective medical staffhave become better positioned to improve individual patient care aswell as each hospital’s individual and collective result.

Pharmacoepidemiology

216. Prevalence of the co-prescription of interacting drugcombinations in cancer patients in Singapore. Alexandre Chan,Pharm.D., M.P.H., BCPS, BCOP, Yu Ko, Ph.D., Judith Kurniawan,M.D.; National University of Singapore, Department of Pharmacy,Singapore, Singapore PURPOSE: This study aims to examine the prevalence of thepotentially interacting drug combinations involving oral anticanceragents (OAAs) that were prescribed and dispensed from two nationalcancer centers in Singapore. METHODS: Sixty clinically important and potentially interactingdrug combinations involving an OAA and a non-anticancer drug wereidentified through predetermined criteria. The prevalence of the co-prescription of these drug combinations between January 1st, 2007and December 31st, 2009 was assessed by a retrospective analysis ofthe pharmacy electronic records databases of National Cancer Center


and National University Hospital, where 85% of all cancer patients inSingapore are treated. Unique drug identifier numbers were used toquery the electronic database to identify patients who were prescribedat least one of the OAAs under examination. A co-prescription wasdefined as either the concurrent prescription of the drug pairs (i.e., onthe same prescription) or one drug whose drug supply overlapped withanother drug with which it may have interacted (i.e., on separateprescriptions). RESULTS: A total of 43,680 prescriptions of OAAs for 8,150patients were reviewed and 637 prescriptions involving a co-prescription (1.46%) were detected in 213 patients (26 per 1,000persons). Approximately half (47.7%) of the interacting combinationswere prescribed on the same prescription. The most commonlydispensed interacting cytotoxic drug combination was methotrexatewith amoxicillin (84 per 1,000 persons), while the most commonlydispensed interacting targeted therapy combination was imatinib andsimvastatin (92 per 1,000 persons). CONCLUSION: The findings of this study shed light on theexistence and extent of DDI prescribing in oncology practice inSingapore. Future research is needed to determine how often theseinteractions actually caused clinically important adverse effects andtheir economic impact.

217. Can the risk of ovarian cancer be reduced by the use ofaspirin, mon-aspirin nonsteroidal anti-inflammatory drugs, oracetaminophen? A large population-based case-control study. Wei-Hsuan Lo-Ciganic, M.S.1, Roberta B. Ness, M.D., M.P.H.2, ClareannH. Bunker, Ph.D.1, Janice Zgibor, R.Ph., Ph.D1; (1)Department ofEpidemiology, GSPH, University of Pittsburgh, Pittsburgh, PA; (2)TheUniversity of Texas School of Public Health, Houston, TX PURPOSE: To evaluate the association between the use of aspirin,non-aspirin nonsteroidal anti-inflammatory drugs (NA-NSAIDs) andacetaminophen, and the risk of ovarian cancer (OVCA). METHODS: In a population-based, case-control study in WesternPennsylvania, Northern Ohio, and South Western New York State, 902women with incident epithelial OVCA who were diagnosed between02/01/2003–11/31/2008 and 1,802 matched controls were included.Regular use (≥ 2 tablets/week for ≥ 6 months) of aspirin, NA-NSAIDs, and acetaminophen before the reference date (9 monthsbefore interview date) was assessed by in-person interview. Dose-response was evaluated by converting dosages into standardized dailydoses (SDD) (low: <0.5 SDD, moderate: 0.5–1 SDD, high: >1 SDD).Duration of use was assigned into three categories: continuous,current, and past users. Logistic regression was used to calculateadjusted odds ratio (OR) and 95% confidence interval (CI). RESULTS: Overall, 489 cases and 1,015 controls reported havingused one or more of aspirin, NA-NSAIDs, or acetaminophen on aregular basis. The OR for aspirin use was 0.81 (95% CI: 0.63, 1.03,p=0.09). Decreased risks were significant among those who usedaspirin continuously (OR: 0.71, 95% CI: 0.54, 0.94, p=0.02), at low-SDD (OR: 0.72, 95% CI: 0.53, 0.97, p=0.03), for prevention ofcardiovascular disease (0.72, 95% CI: 0.57, 0.97, p=0.01), used aspirinrecently, or used cycloxygenase-2 (COX-2) inhibitors (OR: 0.60, 95%CI: 0.39, 0.94, p=0.03). Non-significant results were found amongnon-selective NA-NSAIDs and acetaminophen users. CONCLUSION: Risk reductions of OVCA were observed whenwomen used aspirin or COX-2 inhibitors. The use of other analgesicsis unlikely to be related to the risk of ovarian cancer. Given theinconsistent results and inherent study limitations and biases fromobservational studies, it is too early to suggest that aspirin or COX-2inhibitor use could prevent OVCA as a public-health recommendation.

Pharmacogenomics/Pharmacogenetics

218. Risks, rewards and the double-edged sword:pharmacogenetic testing and research in the AlaskaNative/American Indian community. Jennifer Shaw, M.A.1, ReneeRobinson, Pharm.D., M.P.H.1, Helene Starks, Ph.D., M.P.H.2, WylieBurke, M.D., Ph.D.2, Denise Dillard, Ph.D.1; (1)SouthcentralFoundation, Anchorage, AK; (2)University of Washington, Seattle,WA PURPOSE: Pharmacogenetics is the study of how variations in thehuman genome affect medication response. Pharmacogenetic testing

(PGX) can increase safety and efficacy of drug treatment. However,little is known about how Alaska Native and American Indian people(AN/AI) view PGX and pharmacogenetic research (PGR). This studyexplored the views of the AN/AI community on PGX and PGR tounderstand how these views could inform future research and clinicalpractice. METHODS: We conducted four focus groups with AN/AI adults toelicit views about using PGX in several clinical scenarios and viewson participating in PGR. Focus groups were stratified by age (<40years of age and ≥ 40 years of age), transcribed, coded and analyzedusing thematic analysis. RESULTS: Three key themes emerged from the data: risks of PGX,rewards of PGX and the “double-edged sword” of balancing risks andrewards for optimal benefit to the individual, community andhealthcare institutions. Most participants support use of PGX and PGRif contingencies are met, such as: protection of participantconfidentiality, respectful communication, appropriate consentprocedures and inclusion of AN/AI people in the development andimplementation of research. CONCLUSIONS: AN/AI adults in our sample mostly support usingPGX and pharmacogenetic research in their communities for thepotential rewards of optimized pharmacotherapy, reduced side effects,improved health outcomes, medical advancement and communitydevelopment. These perceived rewards are balanced by contingenciesthat protections be in place to mitigate potential risks. Concerns aregrounded in awareness of the potential misuse of data and historicaldistrust of non-community-based, non-participatory research methods.Understanding perceived risks and rewards of PGX and PGR isessential to the effective application and utilization of thesetechnologies in AN/AI communities.

219. Association of the �-glutamyl carboxylase (CAA)16/17 repeatpolymorphism with higher warfarin dose requirements AfricanAmericans. Larisa H. Cavallari, Pharm.D.1, Minoli Perera,Pharm.D., Ph.D.2, Gelson Taube, Pharm.D.1, Shitalben R. Patel, M.S.1,Keston Aquino-Michaels, B.A.2, Marlos A.G. Viana, Ph.D.1, Nancy L.Shapiro, Pharm.D.1, Edith A. Nutescu, Pharm.D.1; (1)University ofIllinois at Chicago, Chicago, IL; (2)University of Chicago, Chicago,IL PURPOSE: Little is known about genetic variants contributing tohigher than usual warfarin dose requirements, particularly for AfricanAmericans. We assessed the hypothesis that the gamma-glutamylcarboxylase (GGCX) genotype contributes to warfarin doserequirements >7.5 mg/day in African Americans. METHODS: A total of 338 African Americans on a stable dose ofwarfarin were genotyped for the GGCX rs10654848 (CAA)n;VKORC1 c.-1639G>A; and CYP2C9*2, *3, *5, *8, and *11genotypes, and 211 of these patients were genotyped for GGCXrs12714145 (G>A) and rs699664 (p.R325Q). The GGCX variantswere tested for their association with dose requirements >7.5 mg/dayalone and in the context of other variables known to influence doserequirements. RESULTS: The GGCX rs10654848 (CAA) 16 or 17 repeat occurredin 5% of African Americans and was overrepresented among patientsrequiring >7.5mg/day (n=86) versus those who required lower doses(12% vs 3%, p=0.003; OR 4.0, 95% CI, 1.5–10.5). The GGCXrs10654848 genotype remained associated with dose requirements>7.5 mg/day on regression analysis including age, body size, andVKORC1 genotype (p=0.008). Neither the rs12714145 nor rs699664variant was associated with warfarin dose. CONCLUSION: The GGCX rs10654848 (CAA) 16 or 17 repeat ispredictive of warfarin dose requirements >7.5 mg/day in AfricanAmericans. This variant may be useful in identifying warfarincandidates who will require higher than usual warfarin doses.

220. Endothelial nitric oxide synthase polymorphisms andendothelial function in coronary artery disease patients. SavannaSteele, Pharm.D.1, Bryant Tran, Pharm.D., M.S.1, Kyle J. Ellis,Pharm.D.1, Almasa Bass, Pharm.D.1, Robert N. Schuck, Pharm.D.1,Melissa Caughey, RVT., M.P.H.2, George A. Stouffer, M.D.2, Alan L.Hinderliter, M.D.2, Craig R. Lee, Pharm.D., Ph.D.1; (1)EshelmanSchool of Pharmacy, University of North Carolina, Chapel Hill, NC;(2)Division of Cardiology; School of Medicine, University of North

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Carolina, Chapel Hill, NC PURPOSE: Impaired nitric oxide-mediated vasodilation (endothelialdysfunction) is predictive of prognosis in coronary artery disease(CAD) patients. Since identifying individuals predisposed toendothelial dysfunction could help guide therapy, we sought tocharacterize the relationship between genetic variants in endothelialnitric oxide synthase (eNOS:-786T>C, Glu298Asp) and digitalperipheral arterial tonometry (PAT), an emerging method to assessendothelial function. METHODS: Using a cross-sectional design, we studied 110 patientswith established CAD (≥50% stenosis in ≥1 major coronary artery)59±34 () days following cardiac catheterization after fasting overnightand withholding morning medications. After induction of reactivehyperemia by suprasystolic forearm cuff occlusion for 5 minutes,digital PAT was measured using the EndoPAT2000 device andexpressed relative to baseline (PAT-ratio). Associations between PAT-ratio (log-transformed) and genotype were evaluated by regression. RESULTS: Subjects were 60±9 years old, 69% male, and 19%African-American (AA); 57%, 82% and 93% were receiving ACEinhibitors, beta-blockers and statins, respectively. Racial differences inminor allele frequency were observed for -786T>C (AA: 0.125; non-AA: 0.328) and Glu298Asp (AA: 0.075; non-AA: 0.339). PAT-ratiowas lower in variant -786C allele compared to wild-type, respectively[0.29±0.13 (n=55) vs. 0.34±0.13 (n=55), p=0.051; non-AA only:0.29±0.13 (n=50) vs. 0.35±0.13 (n=40), p=0.037]. No association withGlu298Asp was observed (All: p=0.334; non-AA only: p=0.301).After stratifying by race, we assessed the additive contribution of eachpolymorphism by comparing PAT-ratio in non-AA’s carrying 0 [wild-type for both; 0.33±0.11 (n=23)], 1 [0.36±0.15 (n=29)], 2 [0.28±0.12(n=26)], 3 [0.28±0.13 (n=9)] and 4 [homozygous for both; 0.23±0.043(n=3)] variant alleles (p for trend=0.076). Non-AA subjects carrying2–4 variant alleles had significantly lower PAT-ratio compared tothose carrying 0-1 [0.27±0.12 vs. 0.35±0.13, respectively; p=0.005]. CONCLUSION: The eNOS -786T>C and Glu298Asppolymorphisms appear to additively impair endothelial function inCAD patients. Validation of associations between eNOS genotype,digital PAT-ratio and outcomes remains necessary.

Pharmacokinetics/Pharmacodynamics/DrugMetabolism/Drug Delivery

221E. Population probability of target attainment of Telavancin atdifferent levels of renal function against methicillin resistantStaphylococcus aureus in US medical centers. Andras Farkas,Pharm.D., Catherine Hoffman, MT, ASCP; Nyack Hospital, Nyack,NY PURPOSE: Telavancin (TLV) is a first in its class bactericidallipoglycopeptide antibiotic with excellent susceptibility profile againstStaphylococcus aureus. The aim of our study was to describe theCumulative Fraction of Response (CFR) achieved by TLV packageinsert (PI) recommendations and alternative dosing regimens against apopulation of MRSA isolates in US Medical Centers. METHODS: Pharmacokinetic data in patients with renal dysfunction(ECCMID 2004, Poster #1028, n=29) and MIC data of 2500 MRSAisolates for TLV (AAC 2010, June) was used in this analysis.Probability of Target Attainment (PTA) at different levels of renalfunction was established with Monte Carlo Simulation (MCS,n=5000) for MIC ranges of 0.125 to 2 mg/L. Then, CFR wascalculated targeting a ƒAUC/MIC ratio of at least 50 for PIrecommendations. Additionally, lower doses of 5 mg/kg and 7.5mg/kg were evaluated at 24 and 48 hours intervals to assess theirpopulation probability of target attainment for recently documentedMRSA MIC distribution. RESULTS: PI recommended TLV dosing regimens are expected toachieve the CFR of > 95% at all renal function categories from20–120 ml/min. The MCS also showed that CFRs similar to thatachieved by PI recommendations can be reached when using lowerdaily doses of TLV: 7.5 mg/kg q48h for creatinine clearance of 20–40ml/min, 5 mg/kg q24h for 41–80 ml/min, and 7.5 mg/kg q24h for81–120 ml/min. CONCLUSION: We conclude that for the treatment of MRSAinfections to achieve the bactericidal effect of 3 log10 reduction inCFU, the approved dosing regimens provide excellent coverage.

Moreover, current activity of TLV against MRSA in the US wouldallow the use of lower daily doses without compromising the chanceof clinical success Presented at 51st Interscience Conference on Antimicrobial Agentsand Chemotherapy, Chicago, IL.

222. Drug-drug interaction of Eslicarbazepine Acetate withantiepileptic drugs. Gary Maier, Ph.D.1, Mark Versavel, M.D., Ph.D.,MBA1, Jacqueline Zummo, M.S., M.P.H., MBA1, David Blum, M.D.1,Jahnavi Kharidia, Ph.D.1, Patricio Soares-da-Silva, M.D., Ph.D.2;(1)Sunovion Pharmaceuticals, Inc., Marlborough, MA; (2)BIAL -Portela & Ca, SA, Mamede do Coronado, Portugal PURPOSE: Eslicarbazepine acetate (ESL) is a novel antiepilepticdrug (AED) administered once-daily (QD) in clinical development inthe U.S. To evaluate Drug-Drug Interactions (DDIs) of ESL withconcurrent AEDs. METHODS: DDIs of AEDs were evaluated in Phase I studies of ESL1200 mg QD coadministered with lamotrigine (150 mg), topiramate(200 mg), and phenytoin (300 mg). In addition, DDIs ofcoadministered ESL 1200 mg QD with carbamazepine (1200 mg),phenobarbital (150 mg), levetiracetam (750–4000 mg), gabapentin(800–3600 mg), or valproate (250–2000 mg) were evaluated byperforming population pharmacokinetic analyses on data obtainedfrom two Phase III trials in adults with partial onset-seizures. RESULTS: In Phase I studies, coadministration of ESL decreased theexposure of lamotrigine (14%) and topiramate (18%); and increasedthe exposure of phenytoin (12–35%). In the same subjects,lamotrigine, topiramate and phenytoin decreased the exposure of ESLby 4%, 7%, and 33%, respectively. In the population pharmacokineticanalysis, coadministration of ESL resulted in a decrease in exposure oflevetiracetam (14%) and carbamazepine (4–11%); and the exposure ofESL was decreased with carbamazepine (10–24%) and phenobarbital(21%); and increased with valproate (9–29%). No clinically relevantchange in exposure was seen in the remaining AED studied. CONCLUSION: In these studies, no clinically relevant DDIs wereobserved when eslicarbazepine acetate was coadministered withlevetiracetam, gabapentin, lamotrigine, topiramate, or valproate.Based on these results, no dose adjustment of any of these AEDs orESL is anticipated. In contrast, coadministration of carbamazepine,phenytoin and phenobarbital led to potentially clinically meaningfulreductions in ESL exposure. Therefore the dose of ESL may need tobe increased and should be guided by both pharmacokinetic andclinical response considerations. Alterations in exposure to phenytoinsuggest that monitoring of phenytoin plasma concentrations may bewarranted.

223. Exposure-response analysis of Eslicarbazepine Acetateadjunctive treatment of patients with partial-onset seizures.Jahnavi Kharidia, Ph.D.1, Julie Passarell, M.A.2, Gary Maier, Ph.D.1,Jacqueline Zummo, M.S., M.P.H., MBA1, Elizabeth Ludwig,Pharm.D.2, Ted Grasela, Pharm.D., Ph.D.2, Jill Fiedler-Kelly, M.S.2;(1)Sunovion Pharmaceuticals, Inc., Marlborough, MA; (2)CognigenCorporation, Buffalo, NY PURPOSE: Eslicarbazepine acetate(ESL) is a novel antiepilepticdrug (AED) under clinical development in the U.S. for adjunctivetherapy in adults with partial-onset seizures. Exposure-response (ER)models were developed to quantify the relationships between exposureto the active metabolite (eslicarbazepine) and seizure frequency (SF),as well as the probability of response (PR). METHODS: Data from 628 patients providing 1253 weekly SFs werepooled from two Phase 3 trials (8-week baseline, 2-week titration, 12-week maintenance) of adjunct once-daily ESL 400, 800, 1200 mg orplacebo. SF was described as the sum of baseline, placebo, and drugeffects expressed as a saturable Emax function of average steady-stateconcentration (Cav-ss). Using logistic regression, PR (> 50% reductionin standardized SF/28 days from baseline to maintenance) wasdescribed as the sum of a constant placebo effect and a drug effectexpressed as a linear function of Cav-ss. Drug exposures were estimatedusing a previously validated population PK model. RESULTS: Estimated SF was 8.7 seizures/28 days in the placebogroup, and 7.3, 6.7, and 6.6 seizures/28 days in the ESL 400, 800, and1200 mg groups, respectively. The maximal drug effect was predictedto be related to the baseline SF; a higher maximum drug effect is


expected with higher baseline SF. Half of the maximum effect ispredicted with eslicarbazepine Cav-ss of 1970 ng/mL (less than themedian value associated with the lowest dose of 400 mg). EstimatedPR was 0.19 for patients receiving placebo and 0.28, 0.33, and 0.38for patients with the median values of Cav-ss associated with the ESL400, 800, and 1200 mg dose groups, respectively. CONCLUSION: Overall, these ER models support an ESLmaintenance dose of 800-1200 mg QD. Based on this analysis and theshallow ER relationship, and the safety profile of ESL observed in itsclinical development program to date, plasma concentrationmonitoring is not required to guide therapeutic dosing.

224. Population pharmacokinetics of Eslicarbazepine Acetate inpatients with partial-onset seizures. Jahnavi Kharidia, Ph.D.1, MarkVersavel, M.D., Ph.D.1, Qiang Lu, Ph.D.2, Jacqueline Zummo, M.S.,M.P.H., MBA1, Elizabeth Ludwig, Pharm.D.2, Ted Grasela, Pharm.D.,Ph.D.2, Jill Fiedler-Kelly, M.S.2, Gary Maier, Ph.D.1; (1)SunovionPharmaceuticals, Inc., Marlborough, MA; (2)Cognigen Corporation,Buffalo, NY PURPOSE: Eslicarbazepine acetate (ESL) is a novel antiepilepticdrug (AED) under clinical development in the U.S. for adjunctivetherapy in adults with partial-onset seizures. A populationpharmacokinetic (PK) model for eslicarbazepine (the activemetabolite) was developed and the influence of selected covariateswas investigated. METHODS: Full profile and sparse data from 517 subjects in twoPhase 3 studies (1484 concentrations) at once-daily doses of ESL400–1200 mg were available. A 1-compartment model with first-orderabsorption and elimination was developed to describe eslicarbazepinePK. RESULTS: The apparent oral clearance (CL/F) and volume ofdistribution (V/F) were modeled as allometric functions of weight:CL/F´wt0.75 and V/F´wt1. Estimated basal CL/F was 3.66 L/h, with anincrease to 4.75 L/h with concurrent phenobarbital orphenobarbital�like metabolic inducers (phenytoin, primidone). CL/Fwas increased by 11.2–33.7% in patients administered concurrentcarbamazepine (at daily dose of 400–1200 mg) compared to patientsonly receiving ESL. In contrast, CL/F was decreased by 6.9–19.3% inpatients administered concurrent sodium valproate [for the median(49.8 μg/mL) to maximum (140 μg/mL) observed valproateconcentration] compared to patients administered ESL alone. Tissuedistribution of eslicarbazepine is extensive, with the typical V/Festimated to be 81.7 L. A visual predictive check indicated no apparentbiases in the overall model fit. CONCLUSION: The development of this population PK model foreslicarbazepine supported individual subject exposure estimation forthe Phase 3 population PK/PD efficacy analyses.

225. Drug monitoring system in interstitial fluid: feasibility studiesof valproic acid, methotrexate, gentamicin, and theophylline. TonyKL Kiang, Ph.D.1, Urs O. Häfeli, Ph.D.2, Boris Stoeber, Ph.D.3,Beverly Chua, DVM4, Morris Pudek, Ph.D.5, Mary H.H. Ensom,Pharm.D.1; (1)Faculty of Pharmaceutical Sciences, The University ofBritish Columbia & Child and Family Research Institute, Vancouver,BC, Canada; (2)Faculty of Pharmaceutical Sciences, The University ofBritish Columbia, Vancouver, BC, Canada; (3)Departments ofMechanical and Electrical & Computer Engineering, The Universityof British Columbia, Vancouver, BC, Canada; (4)Animal Care Centre,The University of British Columbia, Vancouver, BC, Canada;(5)Vancouver General Hospital, Vancouver, BC, Canada PURPOSE: Using an established rabbit model, this study compareddrug concentration-time profiles of valproic acid, methotrexate,gentamicin, and theophylline in interstitial fluid (ISF) and serum, inorder to assess the feasibility of therapeutic drug monitoring (TDM) inISF and to design future alternative sampling methods for patients. METHODS: An ultrafiltration probe (UF-3-12, BioanalyticalSystems Inc) for ISF collection was implanted subcutaneouslybetween the shoulders of rabbits (n = 6/group). On day 3 post-implantation, an intravenous bolus of valproic acid (50 mg/kg) andmethotrexate (15 mg/kg) or gentamicin (50 mg/kg) and theophylline(12 mg/kg) were administered into the ear vein. Serial (0 up to 24 hpost-dose) ISF and serum concentrations were measured byfluorescence polarization immunoassay (valproic acid and

methotrexate) and particle enhanced turbidimetric inhibitionimmunoassay (gentamicin and theophylline). Area-under-the curves(AUCs) were generated using noncompartmental pharmacokineticmodeling.RESULTS: Of the 4 drugs tested, only methotrexate (mean±SD,27.3±6.7 vs. 29.5±3.7 μmol×h/L) and gentamicin (176.4±54.2 vs.145.7±40.7 μgxh/mL) had comparable AUCs in ISF and serum,respectively. The AUCs of valproic acid and theophylline were bothlower in ISF. A reduced Cmax and increased Tmax in ISF wereevident for all 4 drugs, but their concentration-time profiles wereapproximately proportional in the two matrices, except for gentamicin(that exhibited apparently different concentration profiles in ISF andserum, despite similar AUCs).CONCLUSION: Our novel findings demonstrate feasibility ofquantifying methotrexate levels in ISF. A limitation is the apparentmeasurement delay, which can be corrected with pharmacokineticmodeling. Experiments are ongoing with other drugs that warrantTDM in the rabbit model, and clinical studies examining feasibility ofmethotrexate ISF monitoring are being planned in pediatric patients.The ultimate goal is to eliminate the need for blood sampling forpatients with fragile/“bad” veins, neonates, infants and children forwhom blood sampling is difficult.

226. Drug monitoring system in interstitial fluid: a preliminarystudy of vancomycin and tacrolimus drug concentrations. TonyKL Kiang, Ph.D.1, Urs O. Häfeli, Ph.D.2, Boris Stoeber, Ph.D.3,Beverly Chua, DVM4, Morris Pudek, Ph.D.5, Mary H.H. Ensom,Pharm.D.1; (1)Faculty of Pharmaceutical Sciences, The University ofBritish Columbia & Child and Family Research Institute, Vancouver,BC, Canada; (2)Faculty of Pharmaceutical Sciences, The University ofBritish Columbia, Vancouver, BC, Canada; (3)Departments ofMechanical and Electrical & Computer Engineering, The Universityof British Columbia, Vancouver, BC, Canada; (4)Animal Care Centre,The University of British Columbia, Vancouver, BC, Canada;(5)Vancouver General Hospital, Vancouver, BC, Canada PURPOSE: Using a rabbit model and vancomycin and tacrolimus asprobes, the purpose of this study was to compare drug concentration-time profiles in interstitial fluid (ISF) and blood, in order to designfuture alternative sampling methods for therapeutic drug monitoring inpatients. METHODS: An ultrafiltration probe (UF-3-12, BioanalyticalSystems Inc) for ISF collection was implanted subcutaneouslybetween the shoulders of two rabbits. On day 3 post-implantation, anintravenous bolus of vancomycin (20 mg/kg) and tacrolimus (0.1mg/kg) was administered into the ear vein. Serial (0 to 8 h post-dose)ISF and blood concentrations were measured by fluorescencepolarization immunoassay (vancomycin) and liquid chromatography-mass spectrometry (tacrolimus), and area-under-the curve (AUC)generated by non-compartmental analysis. Glucose concentrations,known to equilibrate between ISF and blood, served as the positivecontrol. RESULTS: Glucose concentrations (ISF and blood) weresuperimposable, confirming the suitability of this rabbit model.Mean±SD vancomycin AUCs (μg×h/mL) in ISF (99.2±6.9) and blood(102.2±3.9) were similar, but a measurement delay was clearlyapparent, as indicated by the time to maximal concentration in ISF of~ 90 minutes. In contrast, ISF tacrolimus concentrations wereundetectable, despite readily detectable levels in the blood. CONCLUSION: Our novel findings demonstrate feasibility ofquantifying vancomycin levels in ISF. A limitation is the apparentmeasurement delay, which can be corrected with pharmacokineticmodeling. However, physiochemical properties of a drug may limit theutility of ISF sampling, as evidenced by tacrolimus (i.e., likely trappedin the blood due to binding to proteins and red blood cells). Furtherstudies with select drugs are ongoing in the rabbit model and plannedin patients. The ultimate goal is to eliminate the need for bloodsampling for patients with fragile/“bad” veins, neonates, infants andchildren for whom blood sampling is difficult.

227E. Bioequivalence of immediate-release oxycodone withAversion® Technology (IRO-A), IRO-A with niacin, and acommercially available oxycodone. Mark T. Leibowitz, M.D.1,Cynthia A. Zamora, M.D., FCCP1, Albert W. Brzeczko, Ph.D.2, Jeffrey

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G. Stark, Ph.D.3; (1)Worldwide Clinical Trials Drug DevelopmentSolutions, Clinical Research Services, San Antonio, TX; (2)AcuraPharmaceuticals Inc., Technical Affairs, Palatine, IL; (3)WorldwideClinical Trials Drug Development Solutions, Pharmacokinetics,Austin, TX PURPOSE: To evaluate bioequivalence by comparing thepharmacokinetic characteristics of an immediate-release oxycodonetablet formulated with Aversion® Technology (IRO-A) (AcuraPharmaceuticals, Inc.) with those of branded immediate-release(IRO) (®, Pharmaceuticals, Inc.) and IRO-A with niacin, a similarproduct containing niacin as an aversive agent. METHODS: A phase 1 single-dose, open-label, randomized, 3-period, 3-treatment crossover study involving 40 healthy adultsubjects who received single 15-mg doses of IRO-A, IRO (thereference listed drug), or IRO-A with niacin after fasting overnight.Subjects were male (n=26) or female (n=14) and aged 18–55 yearswith a body mass index 18–30 kg/m2 and a minimum weight of 110 lb.was administered to diminish opioid effects. Plasma samples wereanalyzed using liquid chromatography with tandem massspectrometry. RESULTS:

IRO-A Parameter IRO-A IRO with niacin Tmax, h, mean (SD) 1.18 (0.57) 0.98 (0.40) 1.46 (0.44) Cmax, ng/mL, mean (SD) 34.5 (7.83) 36.5 (8.78) 32.2 (6.02) AUC∞, h•ng/mL, mean (SD) 168.9 (37.53) 163.4 (42.08) 167.0 (37.23)For the log-transformed exposure parameters Adverse events weremild to moderate in intensity and typical of opioid therapy. Flushing,which occurred in the IRO-A with niacin group, is a CONCLUSIONS: IRO-A was bioequivalent to IRO, as well as IRO-A with niacin. Because of Aversion Technology, IRO-A provides analternative to conventional oxycodone therapy that may reducepotential intranasal and intravenous abuse. Presented at American Academy of Pain Management 22nd AnnualClinical Meeting. American Academy of Pain Management. LasVegas, Nevada. September 20–23, 2011.

228. ADME properties of [14C]-ACU-4429 following a single oraldose in healthy volunteers. Suliman Al-Fayoumi, Ph.D., MBA1, JohnW. Chandler, M.D.1, Suresh Mallikaarjun, Ph.D.2, Shiva Patil, Ph.D.2,Ryo Kubota, M.D., Ph.D.1; (1)Acucela Inc., Seattle, WA; (2)OtsukaPharmaceutical Development & Commercialization, Inc., Rockville,MD PURPOSE: ACU-4429, a visual cycle modulator, is an oral drug inearly stage clinical development for the treatment of dry age-relatedmacular degeneration (AMD). ACU-4429 has been shown to inhibitisomerase (RPE65) activity in pre-clinical studies and is designed todecrease levels of toxic by-products linked to the progression of dryAMD. METHODS: A single 40 mg oral dose of [14C]-ACU-4429 wasadministered to 8 fasted healthy male subjects. Pharmacokineticparameters for [14C]-ACU-4429 and its metabolites were assayed inplasma, urine, and feces. Samples at selected intervals/time pointswere analyzed for total radioactivity via accelerator mass spectrometry(AMS). Plasma concentrations of ACU-4429 and the metabolites weredetermined using HPLC-AMS. RESULTS: Following administration, ACU-4429 was readilyabsorbed and eliminated from plasma (tmax 6.0 hours, t1/2 6.1 hours).ACU�4429 and total radioactivity were eliminated from plasma at asimilar rate. AUC0-t, AUC0-inf, and Cmax values were 57-, 56-, and 62-fold higher, respectively, for total radioactivity in plasma than forACU-4429 in plasma, suggesting that the majority of circulating totalradioactivity was associated with ACU-4429 metabolites. Mean Cmaxand AUC0-t for total radioactivity in whole blood were 76% and 74%of those for total radioactivity in plasma, respectively, indicating themajority of the total radioactivity is not preferentially bound to RBCs.Recovery of total radioactivity in urine and feces was approximately95% by 168 hours postdose (91.3% in urine, 4.03% in feces).Elimination was primarily via renal excretion. Mean recovery ofACU-4429 in urine was 0.229% of the dose administered; mean renalclearance of ACU-4429 was 1.23 L/hr. CONCLUSION: Three major circulating metabolites of the parentcompound ACU-4429 were identified, accounting for approximately

29%, 11%, and 11% of the total AUC of circulating radioactivityfollowing administration of [14C]-ACU-4429. Only mild to moderatevisual AEs were observed and all resolved by the end of the study.

229. Lurasidone pharmacokinetics: assessment of the potential fordrug-drug interactions. Antony Loebel, M.D.1, Sheldon Preskorn,M.D.2, Yu-Yuan Chiu, Ph.D.1, Donald Sarubbi, Ph.D.2, MasaakiOgasa, M.S.2, Josephine Cucchiaro, Ph.D.1; (1)SunovionPharmaceuticals, Inc., Ft. Lee, NJ; (2)Clinical Research Institute,Wichita, KS PURPOSE: The aim of the studies summarized here was to evaluatethe potential risk for drug-drug interactions with lurasidone, a newpsychotropic agent approved for the treatment of schizophrenia. METHODS: Seven studies were conducted in subjects to evaluatepotential pharmacokinetic (PK) interactions with single or multiple-dose lurasidone. The PK of lurasidone was evaluated when co-administered with potent or moderate CYP3A4 inhibitors(ketoconazole or diltiazem); with the CYP3A4 inducer rifampin; andwith lithium. Plasma concentration changes in midazolam, a CYP3A4substrate and in an oral contraceptive (Ortho Tri-Cyclen) wereevaluated in the presence of lurasidone. The effect of lurasidone ondigoxin, a P-gp substrate was also investigated. RESULTS: Concomitant administration of lurasidone andketoconazole, a potent CYP3A4 inhibitor, resulted in increasedlurasidone AUC0–72 (9.3-fold) and Cmax (6.8-fold). Coadministrationof lurasidone and diltiazem, a moderate CYP3A4 inhibitor, resulted inincreased lurasidone AUC (2-fold) and Cmax (2.1-fold). Concomitantadministration of rifampin, a strong CYP3A4 inducer, resulted indecreased AUC (19%) and Cmax (15%). Lurasidone at steady stateexhibited weak CYP3A4 inhibition on the CYP3A4 substratemidazolam, while single-dose lurasidone exhibited no meaningfulCYP3A4 inhibition. No PK interaction was observed afterconcomitant administration of lithium 600 mg BID and steady statedosing of lurasidone compared to lurasidone alone. Concomitantadministration of lurasidone had no effect on digoxin (a P-gpsubstrate) suggesting that lurasidone is not associated with P-gpinhibition. Concomitant administration of lurasidone and Ortho Tri-Cyclen® resulted in equivalent AUC0–t and Cmax of ethinyl estradioland norelgestromin relative to Ortho Tri-Cyclen® administered alone. CONCLUSION: Lurasidone exposure significantly increased whenco-administered with the potent inhibitor of cytochrome P450 3A4,ketoconazole and decreased when co-administrated with the strongCYP3A4 inducer, rifampin. Conversely, lurasidone did not inhibiteither CYP3A4 or P-gp to a clinically significant degree. Nointeraction was observed between lithium and lurasidone.

230. Compatibility of adenosine with iodinated contrast agents.Sulayma Naser Agha, B.S., Nicholas B. Norgard, Pharm.D., EdwardM Bednarczyk, Pharm.D.; University at Buffalo- School of Pharmacyand Pharmaceutical Sciences, Buffalo, NY PURPOSE: Little data exist on the compatibility of iodinated contrastagents with other IV materials. Manufacturers currently do notrecommend mixing any drugs with intravascular contrast agents,partly due to the lack of compatibility data. While concurrentadministration can often be avoided, at times it may be desirable orcritical. This study evaluated the physical compatibility of adenosinewith two intravascular contrast agents, iodixanol and iohexol. METHODS: Adenosine was diluted in both iodixanol and iohexol infive ratios for compatibility testing (0 mg adenosine in 10 ml contrast,3 mg adenosine in 9 ml contrast, 9 mg adenosine in 5 ml contrast, 15mg adenosine in 7 ml contrast, 24 mg adenosine in 2 ml contrast).Visual signs of incompatibility, turbidity (measured asspectrophotometric absorbance), and pH were evaluated initially andat 10 minutes, 30 minutes and 1, 2, 4, 6, 24, and 48 hours, and 1 weekafter preparation. All measures were done at room temperature, with 6fold replication. RESULTS: No visual evidence of precipitation or color change wasobserved. The pH did not differ between contrast alone and mixtureswith increasing adenosine concentrations (p = 0.45). No significantchanges in pH were observed at any time point at any adenosineconcentration. The addition of increasing amounts of adenosine didnot result in significant changes in spectrophotometric absorbance (p =0.06). Spectrophotometric absorbance was not significantly changed


at any time point at any adenosine concentration. CONCLUSION: No evidence of incompatibility was observed whenadenosine was mixed either iodixanol or iohexol for up to one week.

231. Relative bioavailability of oral fosphenytoin sodium injectionin healthy volunteers. Kevin Kaucher, Pharm.D.1, Curtis E. Haas,Pharm.D.2, Nicole M. Acquisto, Pharm.D.2, Jeff Huntress, Pharm.D.3,David C. Kaufman, M.D.4; (1)Denver Health Medical Center, Denver,CO; (2)University of Rochester Medical Center, Rochester, NY;(3)University of Rochester Medical Center - Highland Hospital,Rochester, NY; (4)University of Rochester, School of Medicine andDentistry, Rochester, NY PURPOSE: Phenytoin (PHT) sodium injection has been givenenterally to manage the PHT-tube feeding interaction. Fosphenytoin(FPHT) sodium injection is more commonly available in hospitalstoday. The oral bioavailability of FPHT sodium in humans isunknown. The primary objective of this study was to describe thepharmacokinetics of oral FPHT sodium and determine the relative oralbioavailability (FPO) of FPHT sodium injection compared to PHTsodium injection in healthy volunteers. METHODS: Open-label, randomized, single-dose, two-period, two-sequence crossover study with a minimum 7 day washout involving10 healthy volunteers. Both drugs were administered orally at a doseequivalent to 400 mg of PHT acid. Blood samples were collected atbaseline, 0.5, 1, 2, 4, 6, 12, 24, 48, and 72 hours after dosing. SerumPHT concentrations were determined by fluorescence polarizationimmunoassay. For preliminary analysis, AUC0-72h and AUC0-Inf weredetermined by trapezoidal rule and extrapolation of the final serumconcentration. Cmax and Tmax were determined from the observed data.FPO was calculated based on relative areas. The results were comparedusing a Wilcoxon Signed Rank test. RESULTS: The study subjects were 8 females and 2 males with anaverage age of 37.1 ± 16.3 years, weight of 91.8 ± 38.9 kg, and heightof 144.3 ± 45.8 cm. Median (range) AUC0-72h [298 (260–565) vs. 227(176–332) mg/L·h (p=0.002)], AUC0-Inf [386 (323–1027) vs. 329(196–685) mg/L·h (p=0.01)], and Cmax [10.7 (9.0–19.4) vs. 5.0(3.2–8.9) mg/L (p=0.002)] were all significantly greater for FPHT.Median Tmax [1 (0.5–2) vs. 6 (2–24) h (p=0.008)] was significantlyless for FPHT. Median FPO for FPHT was 115% (92–260%). CONCLUSION: FPHT sodium injection was absorbed more rapidlyand to a greater extent following oral administration than PHT sodiuminjection. Further comparison in the presence of continuous enteralfeeding is warranted.

232. Vascular protection with candesartan: beyond blood pressurereduction. Ahmed Alhusban, Pharm.D., Anna Kozak, M.S., Susan C.Fagan, Pharm.D.; Program in Clinical and Experimental TherapeuticsUniversity of Georgia College of Pharmacy;Charlie Norwood VAMedical Center, Augusta, GA PURPOSE: Hypertension is a major risk factor of stroke and it’smanagement has been associated with reduced stroke incidence andrecurrence. ARBs are one of the antihypertensive classes that havedemonstrated particular benefit on stroke in both clinical andexperimental settings. Despite the many hypotheses that have beensuggested to explain the mechanistic pathways by which hypertensionand ARBs affect stroke, there are still many uncertainties to beaddressed. In this study we investigated the interaction betweenhypertension, ARBs and brain derived neurotrophic factor (BDNF); aprotein that has angiogenic and neurogenic effects and have beenshown to positively affect stroke outcome. METHODS: We used human brain microvascular cells andspontaneously hypertensive rats (SHR) to assess the interactionbetween hypertension, candesartan treatment and BDNF at both themolecular and functional levels. RESULTS: Hypertension reduced the expression of the BDNFreceptor while candesartan treatment significantly increased theexpression of BDNF in the brain of SHR a (p<0.05). Candesartansignificantly increased the proliferation and viability of endothelialcells treated with angiotensin II (10-9 µg/ml) (p=0.0031, 0.0001respectively) while ablating the effects of BDNF using a neutralizingantibody significantly reduced the effect of candesartan on cellviability (p=0.0001). Similarly, neutralizing the effects of BDNFsignificantly reduced the ability of candesartan treated cells to

migrate—an initial step for angiogenesis—(p=0.0001). In cells treatedwith very high dose of angiotensin II (1µg/ml) candesartan treatmentsignificantly increased the migration ability of endothelial cells(p=0.0001). CONCLUSION: Hypertension reduced the expression of BDNF andits receptor. The beneficial effects of candesartan may be at leastpartially related to increasing the availability of functioning BDNF.

233. Nephrotoxicity associated with weight based vancomycindosing. Megan Brockman, Pharm.D.1, A. Shaun Rowe, Pharm.D.,BCPS2; (1)The Univeristy of Tennessee Medical Center, Knoxville,TN; (2)The University of Tennessee College of Pharmacy, KnoxvilleCampus, Knoxville, TN PURPOSE: To determine if > 30 mg/kg/day of vancomycin increasesthe risk of nephrotoxicity compared to ≤ 30 mg/kg/day, using linezolidas a comparator. METHODS: This was a retrospective cohort analysis comparingpatients who received vancomycin doses of > 30 mg/kg/day, ≤ 30mg/kg/day or those who received linezolid. Patients were included inthe study if they received at least 2 doses of vancomycin or linezolid,were greater than 18 years of age and resided on a general medicinefloor during the study period. The primary outcome wasnephrotoxicity (increase in serum creatinine of 0.5 mg/dL or 50%above baseline). Secondary objectives included: effect of thecumulative vancomycin dose on nephrotoxicity, time to nephrotoxicityand predictors of nephrotoxicity. RESULTS: A total of 500 patients were included (>30 mg/kg/daygroup [n=189], ≤ 30 mg/kg/day group [n=211] and linezolid group[n=100]). Thirty patients experienced nephrotoxicity; 13 (6.9%) whoreceived > 30 mg/kg/day of vancomycin, 9 (4.3%) who received ≤ 30mg/kg/day of vancomycin, and 8 (8%) who received linezolid. Nosignificant difference was found between any of the groups [> 30mg/kg/day vs. linezolid OR = 0.85; 95% CI (0.34–2.12); ≤ 30mg/kg/day vs. linezolid OR = 0.51; 95% CI (0.19–1.38); > 30mg/kg/day vs. ≤ 30 mg/kg/day OR = 1.65; 95% CI (0.69–3.97)].Cumulative vancomycin dose and time to nephrotoxicity was notsignificantly different between groups. The initial trough level wassignificantly higher in patients who experienced nephrotoxicity (14 vs.10.1, respectively; p=0.016) and was the only predictor fornephrotoxicity. CONCLUSION: Patients who received > 30 mg/kg/day ofvancomycin did not have an increased risk of nephrotoxicitycompared to those who received ≤ 30 mg/kg/day. Patientsexperiencing nephrotoxicity had higher initial trough levels than thosethat did not.

234. Candesartan for prostate cancer: A dose or a class effect?.Ahmed Alhusban, Pharm.D., Ahmad Al-azayzih, Pharm.D., DianaHoung, Pharm.D., Susan C. Fagan, Pharm.D., Somanath P.R Shenoy,Ph.D.; Program in Clinical and Experimental Therapeutics Universityof Georgia College of Pharmacy;Charlie Norwood VA Medical Center,Augusta, GA PURPOSE: Prostate cancer is the second leading cause of cancerrelated death among men in the United States. Therapeutic modalitiesfor prostate cancer ranging from careful monitoring to chemotherapyis suggested based on patient’s age, Gleason score and serum PSAlevels. Recent reports have presented conflicting results with regard tothe association between ARBs and the incidence of cancer;accordingly we have investigated the effect of candesartan treatmenton the proliferation of prostate cancer cells at cellular and molecularlevels. METHODS: Using two metastatic prostate cancer cell lines (PC3 andLNCaP C4-2), we performed cell migration employing a monolayerscratch assay, colony formation assay, viability and proliferationassays in vitro in the presence or absence of various doses ofcandesartan (0–250 µM) and at doses within the therapeuticconcentration of losartan (0–0.2 µM). Concomitantly these studieswere also compared with western analyses for changes in majorintracellular survival pathways with the different doses of candesartan.Experiments were performed in triplicates and data analyses doneusing student t-test and one way ANOVA. RESULTS: Candesartan modulated the migration and colonyformation ability of prostate cancer cells in a dose dependent manner

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(p<0.0001 in both assays), where doses producing concentrations nearthe therapeutic concentration has promoted the progression of cancercells whereas higher doses have inhibited the progression. Similarlylosartan had a dose dependent modulation of prostate cancer cellsprogression within the therapeutic concentration. In additioncandesartan has modulated the viability of prostate cancer cells in adose dependent manner with maximum reduction in viability being at10υM (p<0.001). Findings at the cellular levels were reproduced at themolecular level analysis of survival pathways. CONCLUSION: We conclude that candesartan and losartan have adose dependent modulatory effect on the progression of metastaticprostate cancer cells.

235. Dexamethasone systemic exposure is associated withhyperlipidemia in children with acute lymphoblastic leukemia.Jitesh D. Kawedia, DPh, Ph.D., Wenjian Yang, Ph.D., Deqing Pei,M.S., John C. Panetta, Ph.D., Xiangjun Cai, Ph.D., Cheng Cheng,Ph.D., Chengcheng Liu, B.S., Scott C. Howard, M.D., William E.Evans, Pharm.D., Ching-Hon Pui, M.D., Mary V. Relling, Pharm.D.;St. Jude Children’s Research Hospital, Memphis, TN PURPOSE: Glucocorticoids are essential drugs for the treatment ofacute lymphoblastic leukemia (ALL). Intensive treatment withglucocorticoids, particularly dexamethasone, has contributed toimproved cure rates. The major dose-limiting adverse effect in currentALL clinical trials is glucocorticoid-induced osteonecrosis. Werecently found that high cholesterol concentration, increaseddexamethasone exposure and lower serum albumin concentration areindependent risk factors for osteonecrosis, and serum albumin level isinversely related to dexamethasone plasma exposure. Asparaginaseand glucocorticoids can cause hyperlipidemia but there are few dataon the extent of and risk factors for hyperlipidemia during ALLtherapy. METHODS: We investigated the association of dexamethasoneplasma exposure with serum lipids measured during the first re-induction phase of therapy, and changes compared to baseline levelsduring consolidation phase, in 266 children treated on a front-lineclinical trial (St. Jude Total XV) for ALL. Patients on thestandard/high risk-arm were exposed to more asparaginase than thoseon the low risk-arm. We performed multivariate analyses, adjusting forstandard clinical features and serum albumin as covariates. RESULTS: Mean levels of cholesterol (p=0.0009) and triglycerides(p=1x10-6) increased while HDL (p=0.004) and LDL (p=1x10-5) levelsdecreased after dexamethasone treatment (during re-induction)compared to baseline (consolidation). Multivariate analysis revealedthat plasma dexamethasone exposure was associated with highercholesterol (p=0.001) and triglycerides levels (p=0.0002), but was notassociated with LDL and HDL levels. Lower serum albumin (a markerof asparaginase treatment) was also associated with higher cholesterol(p=0.008) and triglycerides (p=0.004), and with lower HDL levels(p=2x10-5). In addition, patients in the standard/high risk-arm were athigher risk for elevated cholesterol (p=0.003), triglyceride levels(p=0.03) and LDL (p=0.01) compared to those in the low risk-arm. CONCLUSION: Dexamethasone systemic exposure and treatment onthe standard-/high-risk arm, (with more intensive asparaginasetherapy) are risk factors for hypercholesterolemia andhypertriglyceridemia during ALL therapy.

236E. Pharmacokinetic interactions of roflumilast withmedications commonly prescribed for COPD patients. PhillipJennings, Pharm.D.1, Gezim Lahu, M.S.2, Abhijeet Jakate, Ph.D.1,Andreas Hunnemeyer, M.D., M.S.2, Nassr Nassr, M.D.2; (1)ForestResearch Institute, Jersey City, NJ; (2)Nycomed GmbH, Konstanz,Germany, Konstanz, Germany PURPOSE: With increasing age, patients often require treatment withmultiple medications and drug interactions may affect efficacy ortolerability. Roflumilast is an oral, once-daily, selective,phosphodiesterase-4 inhibitor, metabolized by CYP1A2 and 3A4 to itsactive metabolite roflumilast N-oxide (RNO), which accounts for>90% of total phosphodiesterase-4 inhibitory activity (tPDE4i). RNOis cleared by CYP3A4, with a minor contribution from CYP2C19. METHODS: Potential pharmacokinetic interactions and the safety ofco-administration of a single 500µg roflumilast dose with antibiotics,bronchodilators, inhaled corticosteroids, and other typical

representatives of drug classes commonly used by COPD patients orinvolved in drug interactions was evaluated in healthy volunteers.Increases in tPDE4i of >2-fold (>100%) may decrease tolerability andalterations of <2-fold (<100%) are not expected to result in changes inroflumilast safety and tolerability. RESULTS: No clinically relevant interactions were observed forroflumilast and RNO with erythromycin, enoxacin, albuterol,formoterol, montelukast, budesonide, warfarin, midazolam, digoxin,sildenafil, Maalox, theophylline, and ketoconazole. Rifampin reducedtPDE4i by 58% and so may reduce the therapeutic efficacy ofroflumilast. Fluvoxamine (50mg) or cimetidine (400mg) co-administration resulted in 59% or 47% increases in tPDE4i,respectively. Higher doses may alter the tPDE4i in a clinically relevantmanner, but have not been investigated to date. Roflumilast appearedto have no significant pharmacokinetic influence on co-administereddrugs. No safety concerns were revealed and roflumilast co-administration was generally well tolerated with each drug class. CONCLUSION: Roflumilast was generally well tolerated and did notshow clinically relevant interactions in healthy volunteers when co-administered with medications likely to be prescribed to COPDpatients. Published in European Respiratory Journal (Volume 36, Suppl. 54,2010)

237. The effects of repeat doses of albiglutide on thepharmacokinetics and pharmacodynamics of a low-dose oralcontraceptive containing norethindrone and ethinyl estradiol.Mark Bush, Ph.D.1, Rhona Scott, Ph.D.2, Hui Zhi, Ph.D.3, Prapoch(Keng) Watanalumlerd, Ph.D.4, Eric Lewis, M.D.1;(1)GlaxoSmithKline, Research Triangle Park, NC;(2)GlaxoSmithKline, Middlesex UB11 IBT, United Kingdom;(3)GlaxoSmithKline, Reasearch Triangle Park, NC; (4)PPD,Richmond, VA PURPOSE: Albiglutide (ALBI) is a long-acting GLP-1 agonist inphase 3 development. Potential for pharmacokinetic (PK) andpharmacodynamic interactions between ALBI and low-dose oralcontraceptive (OC) containing norethindrone (NE) and ethinylestradiol (EE) were investigated. METHODS: Healthy female subjects (n=23 enrolled; n=18completed; 20–40 y; BMI: 20–30 kg/m2) received OC (0.5 mg NE,0.035mg EE) for 21 days, then inactive tablet for 7 days in periods 1(p1) and 2 (p2). Subjects received ALBI (50 mg) on day 26 of p1 anddays 5, 12, 19 of p2. Serial blood samples for NE and EE PK werecollected. Samples for luteinizing hormone (LH), follicle stimulatinghormone (FSH) and progesterone were collected. RESULTS: Exposures (AUC(0-24h)) of NE and EE were comparablewhen administered alone or with ALBI. A small non-clinicallyrelevant increase in NE Cmax was observed during OC+ALBIadministration. No clinically relevant effects on LH, FSH, orprogesterone were apparent.

Geometric Ratio of LS Means Geometric

OC OC+ALBI LS Means (n=21) (n=18) (90% CI)

EE AUC(0-24h), pg•h/mL 1318 1313 1.00 (0.96–1.04) EE Cmax, pg/mL 155 161 1.04 (0.98–1.10) NE AUC(0-24h), ng•h/mL 131 144 1.09 (1.06–1.14) NE Cmax, ng/mL 15.8 18.9 1.20 (1.11–1.29)

Mean (SD) OC (n=21) OC+ALBI

Maximum LH, mIU/mL 8.55 (3.56) 8.50 (4.49); n=19 Maximum FSH, mIU/mL 3.96 (1.24) 3.75 (1.50); n=19 Progesterone day 1, ng/mL 0.79 (0.21) 0.87 (0.25); n=21 Progesterone day 21, ng/mL 0.71 (0.23) 0.77 (0.17); n=18OC was safe and well-tolerated when coadministered with ALBI.Adverse events (AEs) occurred in 5/23 subjects (21.7%) in p1 and in10/21 subjects (47.6%) in p2. In p2, nausea and vomiting occurred in5/21 subjects (23.8%) and 4/21 (19.0%) subjects, respectively. Allother AEs occurred in 1-2 subjects. CONCLUSION: The combination of OC+ALBI was well-tolerated.No dose adjustment for OC is required during co-administration withALBI. Submit to: Original Research,PK/PD/pharmacometrics/metabolism


238. Inadequate empirical vancomycin dose in non-elderlyneurosurgical patients by conventional dosing regimen. Ming-FangWen, M.S.1, Ting-Ya Yang, M.S.2, Fe-Lin Lin Wu, Ph.D.2, Li-JiuanShen, Ph.D2; (1)Department of Pharmacy, National Taiwan UniversityHospital, Taipei, Taiwan; (2)Graudate Institute of Clinical Pharmacy,College of Medicine, National Taiwan University, Taipei, Taiwan PURPOSE: Inadequate vancomycin peak/trough concentrations wereobserved in neurosurgical patients using conventional vancomycindosage. The aim of the study was to characterize the pharmacokineticproperties of vancomycin for non-elderly neurosurgical patients. METHODS: Retrospective analysis of vancomycin pharmacokineticparameters was performed for 18-64 year-old neurosurgical patientsfrom routine therapeutic drug monitoring data in a medical centerduring 2009-2010. Patients were excluded if they were with renalfailure, unstable renal function, obesity, shock, and third space fluidaccumulation. Patients’ demographic characteristics, mannitol use,cerebrospinal fluid (CSF) drainage, and urine output were recorded ascandidate covariates. Pearson’s and Spearman’s correlation testsfollowed by multiple linear regression analysis were used to assess thecontribution of patients’ covariates. RESULTS: Seventy-two sets of peak/trough serum concentrationsobtained from 53 patients were analyzed. The mean vancomycinclearance (Clv) and volume of distribution (Vd) were 1.83 ± 0.65mL/min/kg (1.29 ± 0.39 folds of creatinine clearance, Clcr) and 0.92 ±0.27 L/kg in the neurosurgical patients. In subgroup analysis, asignificantly higher ratio of Clv/Clcr was observed in ICU patientsthan that in general ward patients, 1.57 ± 0.34 vs. 1.14 ± 0.33 in eachgroup (p<0.05). No difference was observed in the Vd between ICUand general ward patients. Multiple linear regression of vancomycinclearance in the ICU subpopulation showed that CSF drainage andurine output were positively associated with Clv. Urine output was thesecond most significant variable for Clv following Clcr, whichincreased the adjusted R2 of the regression model from 0.70 to 0.76. CONCLUSION: In critically ill non-elderly neurosurgical patients,Clv is significantly elevated when adjusted by individual Clcr. Theequation newly generated in our study may provide a moreappropriate model in these patients. Further studies are necessary tovalidate the equation and investigate the mechanism of thisphenomenon.

239E. Pharmacokinetics, cord blood concentrations, andtolerability of boosted fosamprenavir in pregnancy. Michelle S.Cespedes, M.D.1, Susan L. Ford, Pharm.D.2, Gary E. Pakes,Pharm.D.2, Luis Vargas, B.S.1, Eleanor M. De Candia, RN1, Judith A.Aberg, M.D.1; (1)New York University School of Medicine, NewYork, NY; (2)GlaxoSmithKline, Research Triangle Park, NC PURPOSE: Little is known about the pharmacokinetics of theprotease inhibitor fosamprenavir (FPV) in pregnancy and of theconcentrations of its active metabolite, amprenavir (APV), that areachieved in infant cord blood. METHODS: A phase I, open-label, single-center study wasconducted to evaluate APV pharmacokinetics following twice-dailyFPV 700 mg boosted by ritonavir 100 mg in pregnant HIV-infectedwomen. Steady-state PK was assessed in the second and/or thirdtrimesters and at 4–12 weeks postpartum. Maternal serum and cordblood samples were obtained at the time of delivery. Plasma APVconcentrations were measured by LC-MS/MS, and PK weredetermined using WinNonlin. RESULTS: Pharmacokinetic data were obtained from 10 women (5African-Americans/5 Hispanics; median age 28.6 years). The mostcommon backbone regimen was tenofovir/emtricitabine. FPV waswell tolerated, with no hepatic, renal, or adverse events attributed toantiretroviral therapy. At delivery, all women had viral loads <400c/mL, with 9 undetectable (<50 c/mL). The median (range) AUC (inμg*h/mL), Cmax (in μg/mL), and C12h (in μg/mL) were 26.80(18.49–40.72), 4.32 (3.07–5.87), and 1.35 (0.88–1.67) during thesecond trimester (n=6); 32.77 (17.05–66.42), 5.75 (3.26–10.98), and1.46 (0.66–2.33) during the third trimester (n=9); and 41.73(28.86–79.66), 6.92 (3.56–9.97), and 2.24 (1.17–5.32) postpartum(n=9). Overall, APV AUC was 22-34% lower, Cmax 9-41% lower, andC12h 27–28% lower during pregnancy than postpartum. Mediangestational age of infants was 37.9 weeks, and birth weight was 2909g. All infants were HIV PCR-negative. No growth abnormalities were

observed. Cord blood was obtained from six deliveries; the medianratio of cord blood/maternal APV level was 0.27. CONCLUSION: FPV use during pregnancy was well tolerated.Although APV C12h was 27–28% lower in pregnancy, HIV was wellsuppressed for all subjects at delivery. Maternal and cord bloodconcentrations were above the mean protein binding-adjusted IC50(0.146 µg/mL) for wild-type virus. Presented at the 6th IAS Conference on HIV Pathogenesis, Treatmentand Prevention, Rome, Italy, July 17–20, 2011.

240. Evaluation of newer equations for estimation of renalfunction for utility in drug dosing using an aminoglycosidepharmacokinetic model. Jeremy Fox, Pharm.D., BCPS, Charles H.Rawls III, Pharm.D.; Shenandoah University, Winchester, VA PURPOSE: Several equations exist for estimation of renal function.This study compares estimated renal function to pharmacokinetic datato evaluate the utility of the Cockcroft-Gault (C-G), Modification ofDiet in Renal Disease (MDRD) and Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) equations for drug dosing. METHODS: Medical records of patients who receivedaminoglycoside therapy from January 1, 2008 to December 31, 2009were reviewed. Selected patients received gentamicin or tobramycin,had appropriately drawn peak and trough levels, and had adequatedata to estimate renal function for the three test equations.Pharmacokinetic data were used to calculate a patient?s estimated truerenal function (CrClKe). RESULTS: Of 1000 records reviewed, 37 patients met inclusioncriteria. The most common reason for exclusion was inadequate orinappropriately drawn pharmacokinetic data. The mean deviation ofthe C-G estimation of renal function was 7.4 ml/min below the CrClkeand the mean deviation of the MDRD and CKD-EPI estimations ofrenal function were 0.5 ml/min and 0.7 ml/min above the CrClke,respectively. Using linear regression to predict CrClke, the C-G,MDRD, and CKD-EPI equations produced r2 values of 0.225(p=0.002), 0.224 (p=0.002), and 0.305 (p<0.001) respectively. Whilenot statistically significant (p=0.062), the C-G equation consistentlyoverestimated renal function in males by 3 ml/min and underestimatedrenal function in females by 13 ml/min. The MDRD and CKD-EPIalso overestimated renal function in males by 4.7 ml/min and 4.6ml/min and underestimated renal function in females by 2 ml/min and1.7 ml/min respectively (p=0.52 and 0.5). CONCLUSION: Utility of the MDRD and CKD-EPI equations toestimate renal function for dosing gentamicin and tobramycin isfeasible as an alternative to the Cockcroft-Gault equation. Aprospective study comparing dosing via the MDRD and CKD-EPImethods should be performed. Further analysis of the differences inestimation of renal function in males and females should be studied inlarger sample sizes.

241E. Clinical pharmacokinetics of low-dose cidofovir without andwith concomitant probenecid used for the treatment of persistentBK viremia in renal transplant recipients. Jeremiah D. Momper,Pharm.D., Yang Zhao, Ph.D., Ron Shapiro, M.D., ParmjeetRandhawa, M.D., Kristine Schonder, Pharm.D., RamanVenkataramanan, Ph.D.; University of PIttsburgh, Pittsburgh, PA PURPOSE: Cidofovir, an antiviral nucleotide analog that is FDA-approved for the treatment of CMV infections, is used off-label for thetreatment of BK virus in kidney transplant patients. However, anoptimal dosage regimen has yet to be elucidated for this indication.Therefore, in order to establish the relationship between cidofovirexposure and response, we first investigated the disposition ofcidofovir in kidney transplant recipients and assessed the contributionof renal secretion to the overall clearance of cidofovir by evaluatingthe effect of oral on cidofovir pharmacokinetics. METHODS: Kidney transplant patients between 18–70 years withpersistent BK viremia were enrolled in this study (n=10). Cidofovirdoses ranged from 0.25–0.6 mg/kg weekly. A crossover study designwas employed and the pharmacokinetics of cidofovir RESULTS: The pharmacokinetic parameters of low-dose cidofovir inkidney transplant recipients are displayed below. A linear relationshipwas observed between cidofovir clearance and

Cidofovir +Cidofovir probenecid

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(mean ± SD) (mean ± SD)Dose-adjusted 36.2 ± 3.4 36.7 ± 2.0 Dose-adjusted AUC 0-∞ (251.2 ± 63.8 258.4 ± 55.3 Clearance (mL/min) 83.6 ± 12.4 76.81 ± 10.3 Renal clearance (mL/min) 62.1 ± 9.14 57.5 ± 9.78 (L) 30.9 ± 19.4 31.7 ± 24.6 1/2 (h) 5.5 ± 1.5 5.9 ± 1.2CONCLUSIONS: Cidofovir exhibited dose-independentpharmacokinetics and clearance was linearly related to Presented at American Transplant Congress, The joint meeting of theAmerican Society of Transplant Surgeons (ASTS) and the AmericanSociety of Transplantation (AST), Philadelphia, PA. 30 Apr 2011.

242. Progesterone, a female sex hormone, inhibits CYP3A-mediated metabolism of 17-alpha hydroxyprogesterone caproate,an agent that prevents preterm birth. Yang Zhao, Ph.D1, CourtneyCuppett, M.D.2, WenChen Zhao, M.S.1, Shimin Zhang, M.S.1, SteveCaritis, M.D.2, Raman Venkataramanan, Ph.D1; (1)University ofPIttsburgh, Pittsburgh, PA; (2)Magee-Womens Hospital, Pittsburgh,PA PURPOSE: In a clinical pharmacokinetic study of 17alphahydroxyprogesterone caproate (17-OHPC) in pregnant women, weobserved a large variation in the pharmacokinetics, and a positivecorrelation between the plasma concentration of 17-OHPC andprogesterone. The objective of this study was to determine the effectof progesterone on the metabolism of 17-OHPC, using human livermicrosomes (HLMs).METHODS: Metabolism of 17-OHPC (concentration range from 1.2to 768 µM) was evaluated in pooled human liver microsomes, in thepresence and in the absence of various female sex hormones,progesterone, 17alpha hydroxyprogesterone, estrone, 17beta estradiol,and estriol. High performance liquid chromatography and liquidchromatography-mass spectrometry were utilized to analyze 17-OHPC and its metabolites, respectively.RESULTS: 17-OHPC was rapidly metabolized by the HLMs withformation of two major mono-hydroxylated metabolites as well asfour minor di- and tri-hydroxylated metabolites. The apparent in vitrohalf-life was 49±4 min. A combination of all the hormones, andprogesterone by itself significantly inhibited the hydroxylation of 17-OHPC, whereas the other hormones tested alone had essentially noeffect. Upon 60-min incubation in HLMs, in presence of hormonecombination or progesterone alone, the depletion of substrate was51% or 46% less, and the generation of two major mono-hydroxylatedmetabolites was 21–35% or 23–46% less, than control group withoutany hormones. The effect of progesterone was best described by acompetitive inhibition and the inhibition rate constant (K(i)) was 52µm using a substrate-depletion approach. Inhibitor of CYP3A4,ketoconazole, inhibited 17-OHPC hydroxylation in HLMs mainlythrough a competitive manner with K(i) 0.7 µM.CONCLUSION: These observations suggest that progesterone hasthe capacity to alter the metabolism of 17-OHPC and that variableconcentrations of progesterone in pregnant subjects may contribute tothe observed variability in the pharmacokinetics of 17-OHPC.

243. PK/PD modeling and simulations support development ofMN-221, a novel,hHighly-selective b2-adrenergic agonist fortreatment of acute asthma. Kirk Johnson, Ph.D.1, James R. Bosley,Ph.D.2, Ron Beaver, Ph.D.2; (1)MediciNova, Inc., San Diego, CA;(2)Rosa & Co. LLC, San Carlos, CA PURPOSE: Asthma causes 2 million annual emergency room visitsin US, 500,000 of which result in hospitalizations with an average stayof 3 days. The present modeling study aimed to evaluate the efficacyof MN-221, a novel b2 agonist in asthma patients in addition to thestandard of care (SOC). METHODS: Data from three clinical trials, including a total of 40mild to moderate asthma patients in clinic, and 33 acute patients in theemergency department, were used in the modeling process. In the ED,subjects received the SOC (inhaled albuterol, as needed). Serial bloodsamples were collected to determine the plasma concentrations ofMN-221 and albuterol. FEV1 and heart rate, and (in the ED) QTc weremonitored during each subjects’ study period. A mixed-effectmodeling approach was used to evaluate the PK and PD of MN-221. RESULTS: A 3-compartment model was fitted to the MN-221 plasma

concentration data with typical values for CL and MN-221 steady statevolume of distribution of 27 L/h and 17.9 L, respectively. A mixturemodel represented distributions of and differentiated betweenresponder and non-responder subjects. The estimatate Emax estimatedfrom clinical data is 20% FEV1, and observed FEV1 improvement isclinically and statistically significant. A synergistic model of MN-221and albuterol levels described the observed increase in FEV1 well. CONCLUSION: Addition of MN-221 demonstrated a clearimprovement in FEV1 over SOC alone in treating acute asthmaexacerbations in responder subjects. PK/PD modeling: 1) enabledprediction the effect of MN-221 in acute patients, 2) supported dosingdecisions, 3) predicted the impact of non-responders on trial outcome,and 4) suggested improved timing of FEV1 measurements. Based onthe proposed PK/PD model, further development of MN-221 as a newtreatment for acute exacerbations of asthma is warranted.

Psychiatry

244E. Risperidone-associated prolactin elevation and markers ofbone turnover during acute treatment. Jeffrey R. Bishop, Pharm.D.,M.S., BCPP1, Leah H. Rubin, Ph.D.2, James L. Reilly, Ph.D.2, Mani N.Pavuluri, M.D., Ph.D.2, John A. Sweeney, Ph.D.2; (1)University ofIllinois at Chicago College of Pharmacy, Chicago, IL; (2)University ofIllinois at Chicago Center for Cognitive Medicine, Chicago, IL PURPOSE: To study the acute effects of prolactin elevation on serummarkers of bone formation and resorption in patients treated with theantipsychotic risperidone. METHODS: Thirty participants (63% male, 24±7 years of age)meeting DSM-IV criteria for schizophrenia (n=23), major depressivedisorder with psychotic features (n=4), or bipolar disorder withpsychosis (n=3) were enrolled. At baseline, subjects wereantipsychotic free for at least four half-lives of any prior medication,with 19/33 having no prior exposure to antipsychotic medications.Subjects were evaluated before and after 4 weeks of risperidonetreatment (median daily dose = 3mg/d, range 0.5-6mg/d). Assessmentsincluded symptom ratings, and a.m. blood draws to assesstestosterone, estradiol, leptin, prolactin, osteocalcin (marker of boneformation), and n-telopeptide crosslinks (NTx marker of boneresorption). Primary analysis examined the impact of risperidonetreatment on change on the bone markers and hormone levels frompre- to post-treatment. All analyses controlled for age, sex, andrisperidone dose. RESULTS: Prolactin levels increased significantly from pre- to post-treatment (p<0.001). Increases in prolactin after risperidone treatmentwere significantly associated with increases in NTx markers of boneresorption (OR 5.13, 95%CI 1.31–20.13). Subjects with the largestincreases in prolactin after risperidone treatment had the greatestincreases (worsening) in their NTx markers of bone resorption. CONCLUSION: Study findings suggest that prolactin elevation isassociated with changes in bone physiology very early in the course oftreatment with risperidone. Higher levels of bone resorption occurredin patients with the greatest increases in prolactin. Interestingly, duringthe acute treatment phase, both increases and decreases in boneresorption were observed which may have important implications forprolactin monitoring or the periodic assessment of osteoporosis-related outcomes in patients requiring extended treatment. Presented at Presented at the American College of Neuropsycho-pharmacology Annual Meeting, Miami, FL, Dec 9, 2010

245. Antipsychotic adherence and discontinuation outcomes inschizophrenia patients with metabolic comorbidities: Analysis of24 state Medicaid programs. Iftekhar Kalsekar, Ph.D.1, RaymondMankoski, M.D., Ph.D.2, Dana Goldman, Ph.D.3, Darius Lakdawalla,Ph.D.3, Seth Seabury, PhD4, Diane Ammerman, Pharm.D.5, ZiaRahman, Ph.D., MBA2, Robert Forbes, Ph.D.6; (1)Health Services, USMedical, Bristol-Myers Squibb, Plainsboro, NJ; (2)Bristol-MyersSquibb, Plainsboro, NJ; (3)Schaeffer Center for Health Policy andEconomics, Los Angeles, CA; (4)RAND Corporation, Santa Monica,CA; (5)Bristol-Myers Squibb, Cranberry Twp, PA; (6)OtsukaPharmaceutical Development and Commercialization Inc., Princeton,NJ PURPOSE: To compare discontinuation and adherence rates tosecond-generation antipsychotics (SGAs) in patients with


schizophrenia and comorbid metabolic abnormalities. METHODS: A retrospective cohort analysis of claims data from 24state Medicaid programs (2001–2005) was conducted. The cohortconsisted of schizophrenia patients who were new users of SGAtherapy and were diagnosed with metabolic syndrome, dyslipidemia,diabetes mellitus, or obesity at baseline. The index date was the filldate of the earliest SGA adopted. SGAs were categorized as high(olanzapine), discrepant (quetiapine and risperidone), or low(aripiprazole and ziprasidone) metabolic risk based on the AmericanDiabetes Association/American Psychiatric Association consensusguidelines. Adherence was defined as a medication possession ratio(MPR) of >80% between first and last prescription fill of the indexSGA. Discontinuation was defined as a gap in therapy of more than 60days. The outcomes were evaluated in the 12-month period after theindex date. Logistic regression was used to assess the impact ofmetabolic risk of SGA on adherence and discontinuation rates aftercontrolling for demographics, comorbidity, and baseline psychiatriccharacteristics. RESULTS: A total of 21,857 patients meeting the study criteria wereidentified. The mean age of the sample was 46.1 (±10.2) years and themajority of the patients were female (56.6%) and non-white (63.8%).Logistic regression results demonstrated that patients prescribed highmetabolic risk SGAs were 38% less likely to be adherent (p<0.001)and patients prescribed discrepant metabolic risk SGAs were 21% lesslikely to be adherent (p=0.006) relative to patients prescribed lowmetabolic risk SGAs. Patients prescribed high or discrepant metabolicrisk SGA had higher odds of discontinuation (Odds Ratios of 2.29(p=0.006) and 1.18 (p<0.001), respectively). CONCLUSIONS: Use of discrepant or high metabolic risk SGAs isassociated with poorer adherence and higher rates of discontinuationin schizophrenia patients with comorbid metabolic conditions.

246E. Determining rates of metabolic monitoring in clozapine-treated outpatients: evaluating the need for a collaborativemetabolic monitoring service. Ted J. Turner, Pharm.D.1, Jamie L.Montgomery, R.Ph., BCPP1, Melissa S. McGivney, Pharm.D., FCCP2,Kim C. Coley, Pharm.D., FCCP2, Tanya J. Fabian, Pharm.D., Ph.D.,BCPP1; (1)Western Psychiatric Institute and Clinic, University ofPittsburgh Medical Center, Pittsburgh, PA; (2)University of PittsburghSchool of Pharmacy, Pittsburgh, PA PURPOSE: The risk of metabolic syndrome and premature mortalityis high in patients with serious mental illness. Atypical antipsychoticscan cause weight gain, hyperglycemia and hyperlipidemia. Among theavailable atypical antipsychotics, clozapine is reserved for treatmentresistant patients and is associated with the highest risk of metabolicsyndrome. The purpose of the present project was to determinemetabolic monitoring rates compared to the 2004 American DiabetesAssociation (ADA) recommended guidelines in at an outpatientclozapine clinic. METHODS: Electronic medical records of patients enrolled in anoutpatient clozapine management clinic were retrospectively reviewedbetween January 2005 and December 2010, and the following dataelements were extracted: (1) date of clozapine initiation, (2) date andvalue of metabolic parameters including blood pressure, weight, waistcircumference, fasting lipid and glucose levels, and (3) diagnosis andpharmacological treatment of hypertension, diabetes, obesity ordyslipidemia. RESULTS: A total of 127 patients (mean age: 47.7 years) wereincluded in the analyses. Of the 34 who initiated clozapine treatmentbetween 2005 and 2010, baseline evaluations (±14 days frominitiation) were: weight 70.6% (24/34), waist circumference 0%(0/34), blood pressure 52.9% (18/34), fasting lipid and glucose levels11.8% (4/34). Within 3 months of initiating clozapine (15–98 days),blood pressure was reevaluated in 80.6% (25/31) of patients; fastinglipids and glucose levels had only been reassessed in 29.0% (9/31) ofpatients. Most patients who were diagnosed with diabetes (26.8%),hypertension (32.3%) or dyslipidemia (55.9%) were being treatedpharmacologically for their condition(s). CONCLUSION: Monitoring of clozapine-induced metabolicdisturbances in this high-risk patient population was not consistentwith ADA recommended guidelines. Additional effort is needed toimprove metabolic monitoring in this high risk population.Pharmacists who oversee hematologic monitoring through the

clozapine management clinic are well positioned to establish ametabolic monitoring clinic in collaboration with the clinicaltreatment team. Presented at Presented at the American Pharmacist Association 2011Annual Meeting in Seattle, WA. March 26th 2011

247. Impact of a Pharmacist on Length of Stay and ReadmissionRate at an Academic Inpatient Psychiatric Unit. Kimberly Tallian,Pharm.D., BCPP, FCCP, FASHP1, Gwendolyn Le, Pharm.D.,Candidate2, Duy Q. Tran, Pharm.D., Candidate2, Sohil N. Rai,Pharm.D., Candidate2; (1)Scripps Memorial Hospital, La Jolla, SanDiego, CA; (2)University of California, San Diego, San Diego, CA PURPOSE: To determine the impact of a psychiatric pharmacist onacute psychiatric patient’s clinical outcomes in an academic medicalcenter including adherence to medications, length of stay, cost-effective pharmacotherapy, and readmission rate. Our secondaryobjective was to determine the influence of a pharmacist guidedpharmacotherapy treatment plan on hospital readmission based on thepatient’s preferences and ability to pay for outpatient medications. METHODS: A retrospective study compared all patients admitted toan academic, inpatient psychiatric unit between January 2006 throughJune 2006 (pre-intervention group without direct pharmacistinvolvement) and January 2010 through June 2010 (post-interventiongroup with direct psychiatric pharmacist involvement utilizing directformulary and clinical services). Data was obtained from acomputerized charting system, pharmacist computerizeddocumentation system, and discharge pharmacy electronic records.Each patient’s ability to access discharge medications was determinedby discharge prescription records pre and post interventions groups. RESULTS: A 25% reduction in pharmaceutical cost per patient and areduction in length of stay by two days (P=0.04) was found in the post(N=405) versus the pre intervention (N=314) group despite nodifference in patient severity upon admitted based on globalassessment of functioning scores (p=1.0). Additional cost savingincluded formulary conversion to enhance medication adherence;generic anticonvulsant conversion; therapeutic drug monitoring; andpharmacist driven formulary to reduce the average medication cost perpatient and readmission rate. Despite improved drug adherence duringadmission, there was no significant difference in dischargeprescription compliance between the two groups (p >0.05), but fewerpatients were readmitted in the post-intervention versus the pre-intervention group (p<0.05). CONCLUSION: Provision of clinical pharmacy services influencedhospital-based medication adherence rates resulting in reduced lengthof stay, but its impact on hospital readmission rates remains unclear.

248. Effect of pharmacy team interventions on monitoring ratesfor second-generation antipsychotics in a correctional setting.Philip J. Wenger, Pharm.D., BCPS, Kyle R. Mays, Pharm.D.; St.Louis College of Pharmacy, Saint Louis, MO PURPOSE: This study was conducted to assess the change inmonitoring rates for second-generation antipsychotics (SGAs) at theBuzz Westfall Justice Center (BWJC) following interventions made bythe clinical pharmacist and students. The interventions includeddevelopment of a written protocol that outlines the necessarymonitoring parameters and frequency for SGAs and a weekly clinicfor the administration of the Abnormal Involuntary Movement Scale(AIMS) to patients referred by mental health providers. METHODS: A retrospective chart review was conducted for BWJCpatients receiving SGAs for the six months from 12-01-2008 to 5-31-2009. The review identified several categories below facility goal ratesof greater than or equal to 80%. The clinical pharmacist and studentsprovided education on the recommended monitoring parameters andfrequencies to the providers at BWJC and instituted a weekly referralclinic for the administration of the AIMS test. A follow-up chartreview was conducted to collect the monitoring rates from 12-01-2009to 5-31-2010. The monitoring rates for each parameter post-intervention were compared to the pre-intervention rates using a chi-squared test with a significance level of 0.05. Parameters monitoredwere body mass index (BMI), fasting plasma glucose (FPG), fastinglipid profile (FLP), AIMS test, liver function tests (LFTs), andcomplete blood count (CBC). RESULTS: Overall rates for BMI, AIMS, and LFTs were statistically

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significantly improved after the pharmacy intervention. Only the ratesfor BMI improved to above the goal rate. No statistically significantdifferences were seen in the overall rates for FPG, FLP, or CBC. CONCLUSION: The initiation of the AIMS clinic has been a positiveimprovement and will continue to be offered. Potential future changesfor improving monitor rates of lab tests include education of all newpsychiatry residents by the pharmacist or routine assessment andlaboratory ordering by pharmacy for all patients taking SGAs.

Pulmonary

249. Appropriateness of chronic obstructive pulmonary disease(COPD) management per global initiative for chronic obstructivelung disease (GOLD) guidelines at a family medicine practice. C.Brock Woodis, Pharm.D.1, Amber N. McLendon, Pharm.D.2, CherylVan Horn, RN3, Dallas Brooks, Pharm.D., Candidate2, CarolineFerguson, Pharm.D., Candidate2, Justin Spivey, Pharm.D., Candidate2;(1)Campbell University College of Pharmacy and Health Sciences andDuke University Department of Community and Family Medicine,Durham, NC; (2)Campbell University College of Pharmacy andHealth Sciences, Buies Creek, NC; (3)Duke University Department ofCommunity and Family Medicine, Durham, NC PURPOSE: This retrospective study evaluated the appropriateness ofCOPD management per GOLD guidelines at a family medicinepractice associated with a major academic medical center. Areasidentified for improvement may be targeted by a pharmacist-managedclinic within the family medicine practice. METHODS: Individuals who were patients of the family medicinecenter and had been assigned an ICD-9 diagnosis of COPD wereidentified by querying the practice’s electronic medical records. Inorder to be included, patients must have been ≥ 42 years of age as of12/31/09, seen 3 times in the past 3 years and once duringmeasurement period (5/1/10–4/30/11) by a provider of the familymedicine center, and had documented COPD staging. Age, race,pulmonary function tests (if available), and current medications forCOPD were recorded. RESULTS: Of the 78 patients reviewed, 71 were included foranalysis. Per GOLD guidelines, 50.7% (36/71) received appropriatemedication management (i.e., bronchodilators and corticosteroids)based on documented COPD stage. Of those who did receiveappropriate management, 11.1% (4/36) received inadequate dosing ofCOPD medications. CONCLUSION: Appropriately staging COPD, as well as reassessingcurrently prescribed medications, inhaler technique, and adherence atfollow-up visits, are vital to patient care. Pharmacists are uniquelypositioned to maximize COPD outcomes. A pharmacist-managedclinic may be of benefit to the multidisciplinary care of COPD patientsand aid in exceeding national measurements. In addition,documentation of COPD management at this particular practice maybe improved.

250. Cost-effectiveness analysis of roflumilast/tiotropiumcombination therapy vs. tiotropium monotherapy in patients withsevere to very severe COPD. Andrew P. Yu, Ph.D.1, Shawn Sun,Ph.D.2, Maryna Marynchenko, MBA1, Ritesh Banerjee, Ph.D.1,Michelle Mocarski, M.P.H.2, Donald Yin, Ph.D.2, Eric Wu, Ph.D.1;(1)Analysis Group, Boston, MA; (2)Forest Research Institute, JerseyCity, NJ PURPOSE: Roflumilast, a once-daily oral selectivephosphodiesterase-4 inhibitor recently approved by the FDA, reducesthe risk of COPD exacerbations in patients with severe COPDassociated with chronic bronchitis and history of exacerbations. Theobjective of this presentation is to conduct a cost-effectivenessanalysis comparing the combination therapy of roflumilast andtiotropium versus tiotropium monotherapy in severe-to-very severeCOPD patients. METHODS: The economic evaluation applied a disease-basedMarkov cohort model with five health states: 1) severe COPD, 2)severe COPD with a history of severe exacerbation, 3) very severeCOPD, 4) very severe COPD with a history of severe exacerbation,and 5) death. Within a given health state, a patient may have amild/moderate or severe exacerbation or die. The probability of eachevent depends on the severity of COPD. Evidence from roflumilast

clinical trials was used to estimate the relative risk of having anexacerbation and the change in lung function in patients treated withroflumilast. Data from published literature were used to populate othermodel parameters. The model calculated health outcomes and costs forroflumilast/tiotropium combination therapy versus tiotropiummonotherapy over a 5-year horizon. Incremental cost and benefitswere then calculated, and expressed as cost-effectiveness ratios,including cost per exacerbation avoided and cost per quality adjustedlife year ($/QALY). RESULTS: Over a 5 year horizon, the estimated incremental costs perexacerbation avoided and per severe exacerbation avoided with theaddition of roflumilast to tiotropium are $589 and $5,869,respectively, and the incremental cost per QALY is $15,815. One-waysensitivity analyses varying key parameters produced an incrementalcost per QALY ranging from $1,963 to $32,773. The cost-effectiveness ratio was sensitive to the relative risk reduction ofexacerbations from adding roflumilast to tiotropium. CONCLUSION: The addition of roflumilast to tiotropium may becost-effective for the treatment of severe-to-very severe COPDpatients.

251. The safety and efficacy of roflumilast: a new treatment toreduce exacerbation risk in severe COPD patients. Nicola A.Hanania, M.D., M.S., FCCP, FRCP(C), FACP1, Mark T. Dransfield,M.D.2, Udo-Michael Goehring, M.D.3, Hans Mosberg, M.D.3, PhillipJennings, Pharm.D.4; (1)Baylor College of Medicine, Houston, TX;(2)University of Alabama, Birmingham, AL; (3)Department ofMedical Scientific Strategy/Respiratory, Nycomed, GmbH, Konstanz,Germany; (4)Forest Research Institute, Jersey City, NJ PURPOSE: COPD is a leading cause of mortality in the US andCOPD exacerbations accelerate disease progression and increasemortality risk. Treatments that reduce exacerbation rates are thereforebeneficial. Roflumilast, an oral, once-daily, selectivephosphodiesterase-4 inhibitor recently approved for patients withsevere COPD, reduces the rate of COPD exacerbations in patientswith chronic bronchitis and a history of exacerbations. Here, data arepresented from key trials evaluating the efficacy and safety ofroflumilast 500μg for COPD treatment. METHODS: Six phase 3 trials (3 pairs of similar studies) were used toevaluate change in exacerbation rates and lung function in COPDpatients. M2-111/M2-112: 1-year trials in severe-to-very severe patientsallowing concomitant ICS use; M2-124/M2-125: 1-year trials in severe-to-very severe patients with a history of exacerbations and chronicbronchitis allowing concomitant LABA use; M2-127/M2-128: 6-monthstudies in moderate-to-severe patients treated concomitantly withsalmeterol or tiotropium, respectively. Fourteen phase 2-3 trials (n=5766roflumilast; n=5491 placebo) evaluated adverse event (AE) frequency. RESULTS: In M2-111/M2-112 (n=1327 roflumilast; n=1359placebo), the moderate/severe exacerbation rate was 14.3% lower withroflumilast versus placebo (P=0.026); in M2-124/M2-125 (n=1537roflumilast; n=1554 placebo) the rate was 16.9% lower (P=0.0003)and median time to first exacerbation was prolonged by 67 daysversus placebo. Prebronchodilator FEV1 increased with roflumilastover placebo by 49mL (P<0.0001) in M2-127 (n=466 roflumilast;n=467 placebo), and 80mL (P<0.0001) in M2-128 (n=371 roflumilast;n=372 placebo). The most commonly reported AEs with roflumilast(≥2% and >placebo) were diarrhea, weight loss, nausea, headache,back pain, influenza, insomnia, dizziness and decreased appetite. CONCLUSION: The safety and efficacy of roflumilast has beenshown in a variety of phase 3 COPD studies, independent ofconcomitant therapy with either ICS or LABAs or LAMAs.Roflumilast is a beneficial treatment for patients with severe COPDtaking concomitant COPD medications as patients may experiencefewer exacerbations.

252E. An evaluation of the management of non-life threateningCOPD exacerbations in hospitalized patients. J. Andrew Woods,Pharm.D., BCPS1, Christopher K. Finch, Pharm, D., BCPS2, Justin B.Usery, Pharm.D., BCPS2, Timothy H. Self, Pharm.D.2; (1)WingateUniversity, School of Pharmacy, Wingate, NC; (2)MethodistUniversity Hospital and University of Tennessee, Memphis, TN PURPOSE: COPD is an increasing cause of morbidity, mortality andeconomic burden on our healthcare system, while exacerbations


continue to be among the top 10 causes of hospitalization in adults.Previous literature has demonstrated that only 66% of patients receive“recommended” care during an acute exacerbation of COPD. Theobjective of this study was to evaluate adherence to GOLD guidelinesfor treatment of severe, non-life threatening COPD exacerbations at auniversity teaching hospital. METHODS: This study was a retrospective chart review of allpatients admitted from January 2007 to June 2008 with a primarydiagnosis of severe, non-life threatening COPD exacerbation (ICD-9code 491.21). Each patient’s COPD treatment regimen was assessedand compared to GOLD guideline recommendations. RESULTS: Two hundred fifty-nine patients met inclusion criteria.The majority of patients were African-American and female with amean age of 69 years. GOLD guidelines were met in 212 patients(81.9%). Length of stay was numerically higher in our patients versusthe national average, 5.3 days vs. 4.8 days (p=NS), respectively.Approximately 66% of the patients in our study received antibioticswith 71% being unwarranted per GOLD guidelines. Systemiccorticosteroids were not administered to 11% of patients CONCLUSION: The potential to improve patient care throughadherence to GOLD guidelines exists as evidenced by 18% of patientsnot receiving therapy per GOLD recommendations, including theadministration of unnecessary antibiotics. In addition, systemiccorticosteroids were not prescribed in all patients with a non-lifethreatening COPD exacerbation. The management of non-lifethreatening COPD exacerbations in hospitalized patients needsimprovement and should be in accordance with well-acceptedinternational guidelines. Efforts should be undertaken to develop atreatment algorithm or protocol to be initiated upon admission to thehospital for such an exacerbation to optimize therapy and patientoutcomes while potentially reducing hospital length of stay. Presented at Presented at the American College of Chest PhysiciansMeeting, Vancouver, BC, Nov 1–4, 2010

253E. An evaluation of inhaled bronchodilator therapy in patientshospitalized for non-life-threatening COPD exacerbations. J.Andrew Woods, Pharm.D., BCPS1, Timothy H. Self, Pharm.D.2,Shaunta’ M. Ray, Pharm.D., BCPS3, Justin B. Usery, Pharm.D.,BCPS2, Christopher K. Finch, Pharm, D., BCPS2; (1)WingateUniversity, School of Pharmacy, Wingate, NC; (2)MethodistUniversity Hospital and University of Tennessee, Memphis, TN;(3)The University of Tennessee College of Pharmacy, Knoxville, TN PURPOSE: COPD afflicts 24 million people and is the fourth leadingcause of death in the United States. For this patient population,overuse and misallocation of respiratory care services is a commonfinding. In fact, nebulized bronchodilator therapy is commonlyprescribed in excess to hospitalized patients despite the equivalentefficacy of metered dose inhalers with valved holding chambers. Theobjective of this study was to evaluate the current practice in themanagement of severe, non-life threatening COPD exacerbations anddetermine the number of missed nebulized respiratory treatments. METHODS: This study was a retrospective chart review of allpatients admitted from January 2007 to June 2008 at two academicmedical centers with a primary diagnosis of severe, non-lifethreatening COPD exacerbation (ICD 9 code 491.21). Each patient’sCOPD treatment regimen was evaluated and the potential fornebulization to metered-dose inhaler (MDI) with valved holdingchamber (VHC) conversion was assessed. The number of missednebulized respiratory treatments was also identified. RESULTS: Two hundred fifty-nine patients met inclusion criteria. Twohundred thirty-five (90.7%) patients received nebulized bronchodilatorsin the treatment of COPD exacerbations; 81.1% of these patients couldhave potentially utilized MDI with VHC. During this time, 11,422nebulized medication doses were scheduled; however, 2,775 (24.3%)were omitted. Patients missed 23% and 26% of scheduled, nebulizedalbuterol and ipratropium doses, respectively. Even the long acting beta-agonist arformoterol was omitted 21.3% of the time. CONCLUSION: The management of non-life threatening COPDexacerbations in hospitalized patients needs significant improvement.The number of missed doses of inhaled therapies is unacceptable andcould potentially be reduced by more patients receiving respiratorytreatments administered via MDI-VHC. Conversion to MDI-VHCcould have significant impact on patient outcomes, length of stay, and

medication cost. The development of a respiratory therapist drivenconversion protocol should be implemented. Presented at Presented at the American College of Chest PhysiciansMeeting, Vancouver, BC, Nov 1–4, 2010

Rheumatology

254E. Febuxostat (FEB) vs. Allopurinol (ALLO) in treating thehyperuricemia of gout in diabetic patients. Michael A. Becker,M.D.1, Patricia MacDonald, NP2, Barbara Hunt, M.S.2, Robert L.Jackson, M.D.2; (1)University of Chicago, Pritzker School ofMedicine, Chicago, IL; (2)Takeda Global Research & DevelopmentCenter, Inc., Deerfield, IL PURPOSE: Gout is commonly associated with cardiovascular, renal,and metabolic comorbidities, including diabetes mellitus. We report onbaseline subject demographics and the efficacy and safety of urate-lowering (UL) therapy in diabetic gout subjects. METHODS: In the 6-month CONFIRMS trial comparing UL withFEB vs ALLO, 312 of 2269 gouty subjects were diabetic by history(72% receiving either insulin or oral hypoglycemic agents). Subjects(baseline sUA >8.0 mg/dL) were randomized to daily FEB 40 mg or80 mg (in subjects with eCLcr ≥30ml/min) or ALLO (300 mg if eCLcr≥60 ml/min, 200 mg if eCLcr 30–59 ml/min). Safety was evaluated byphysical/lab examination and reported adverse events (AEs). RESULTS: Comorbidities were common among diabetic goutysubjects: CVD (86%, including: hypertension [83%], coronary arterydisease [22%], arrhythmias [18%] and MI [10%]); impaired renalfunction (eCLcr <90 ml/min 79%, <59 ml/min 36%); hyperlipidemia(65%); and mean BMI of 36 kg/m2. Years with gout (mean 13), sUAlevels (mean 9.6 mg/dL), and tophi (18%) were similar acrosstreatment groups. UL efficacy among diabetic subjects (final visit sUA<6.0 mg/dL) was 38% for FEB 40mg and 32% for ALLO; FEB 80 mg(75%) was superior to both (p<0.001), a finding also seen in mild andmoderate CKD. Higher sUA and the presence of tophi at baselinewere associated with lower UL efficacy. Non-fasting blood glucoselevels remained stable during UL therapy. At least 1 AE was reportedin 46%, 62%, and 66% of FEB 40 mg-, FEB 80 mg-, and ALLO-treated diabetic gouty subjects. Self-limiting diarrhea and upperrespiratory infections were the most common. Serious AEs occurred in1, 8, and 8 subjects in FEB 40 mg, FEB 80 mg, and ALLO groups,respectively. CONCLUSION: Despite high rates of serious co-morbidities,diabetic gouty subjects tolerated UL therapy with either FEB orALLO, but FEB 80 mg achieved goal range sUA significantly moreoften than ALLO at commonly utilized doses. Presented at Presented at the European League Against Rheumatism(EULAR) 2011 Annual European Congress of Rheumatology.London, UK, May 25–28, 2011.

255E. Pharmacokinetics and pharmacodynamics of tocilizumab insystemic juvenile idiopathic arthritis. Xiaoping Zhang, Ph.D.1, PeterN. Morcos, Pharm.D.1, Fabrizio De Benedetti, M.D., Ph.D.2, HermineBrunner, M.D., M.S.3, Nicolino Ruperto, M.D., M.P.H.4, FelicitySchaefer, M.S.1, Stephanie Roseti, RN, MSN, APN-BC1, AndyKenwright, B.S.5, Alberto Martini, M.D.4, Daniel Lovell, M.D.,M.P.H.3; (1)Roche, Nutley, NJ; (2)IRCCS Ospedale PediatricoBambino Gesù, Rome, Italy; (3)Pediatric Rheumatology CollaborativeStudy Group, Cincinnati, OH; (4)PRINTO-IRCCS Giannina Gaslini,Genova, Italy; (5)Roche, Welwyn, United Kingdom PURPOSE: Tocilizumab (TCZ) is a humanized IgG1 monoclonalantibody against interleukin-6 receptor (IL-6R). TENDER is a phase 3study evaluating efficacy, safety, PK, and PD of TCZ in systemicjuvenile idiopathic arthritis (sJIA). PK, PD, and exposure-responserelationships are reported for 1-year data. METHODS: Patients received TCZ 8 mg/kg (body weight [BW] ≥30kg; TCZ8) or 12 mg/kg (BW<30 kg; TCZ12) intravenous infusionevery 2 weeks. Samples were collected for 12 weeks pre- and post-infusion for population PK analysis. Predose PK and PD samples werecollected for 52 weeks. Area under curve (AUC2wk) and maximumconcentration (Cmax) at week 12 dosing interval were estimated. RESULTS: Among 52 TCZ8 and 50 TCZ12 patients, mean±SD agewas 13.4±2.8 and 5.9±2.8 y; BW was 49.2±18.5 and 18.9±5.4 kg,respectively. For TCZ8 and TCZ12, mean±SD AUC2wk, Cmin, and

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Cmax at week 12 were 1337±409 and 1346±426 μg·d/mL, 69±25 and71±31 μg/mL, and 226±55 and 263±54 μg/mL, respectively. Week 52observed Cmin was 65±31 and 77±28 μg/mL for TCZ8 and TCZ12.Predose TCZ and sIL-6R concentrations stabilized after week 12(Table). Mean CRP and ESR levels decreased rapidly after the firstdose, remaining low through week 52. Adverse events did not increasewith greater TCZ exposure. Proportions of patients achievingACR30/50/70/90 were similar across TCZ AUC2wk or Cmin exposurequartiles. CONCLUSION: Similar PK and PD profiles confirmed two BW-based dosing regimens in sJIA patients. Mean±SD sIL-6R, ESR, and CRP at Baseline and Weeks 2, 12, and 52

sIL-6R, ng/mL ESR, mm/h CRP, mg/LTCZ 8 mg/kg, BW ≥30 kgBaseline 43.0±12.9 54.0±36.9 194.37±456.23 Week 2 482.0±138.2 11.0±12.8 30.15±41.27 Week 12 752.0±214.9 4.0±3.8 0.70±1.26 Week 52 860.0±185.9 4.0±3.1 2.36±11.72 TCZ 12 mg/kg, BW <30 kgBaseline 42.0±11.0 60±31.3 148.24±237.18 Week 2 515.0±135.4 9.0±11.9 19.87±26.08 Week 12 771.0±247.0 3.0±2.5 2.90±18.09 Week 52 881.0±124.6 3.0±2.7 0.18±0.14Presented at (1) EULAR (European League Against Rheumatism)Annual European Congress of Rheumatology; May 25–28, 2011;London, United Kingdom (2) American Society for ClinicalPharmacology and Therapeutics; March 2–5, 2011; Dallas, Texas

256E. Long-Term Safety of Tocilizumab in Rheumatoid ArthritisClinical Trials. Mark C. Genovese, M.D.1, Anthony Sebba, M.D.2,Andrea Rubbert-Roth, M.D.3, Juan J. Scali, M.D.4, Moshe Zilberstein,M.D.5, Liz Thompson, B.S.6, Ronald F. van Vollenhoven, M.D.7;(1)Stanford University Medical Center, Stanford, CA; (2)University ofSouth Florida, Palm Harbor, FL; (3)University of Cologne, Cologne,Germany; (4)Durand Hospital, Buenos Aires, Argentina; (5)Roche,Nutley, NJ; (6)Roche, Welwyn, United Kingdom; (7)KarolinskaInstitute, Stockholm, Sweden PURPOSE: Assess long-term safety of TCZ in RA patients. METHODS: Data from patients receiving ≥1 TCZ dose from initialexposure through 2/17/10 and pooled data from controlled trials andlong-term extension studies. RESULTS: Patients (N=4009) received TCZ (median[mean])duration–3.6 (3.1) years; total observation time–12,293 patient-years(PY). Rates of SAEs, serious infections (SIs), MI, and stroke remainedstable over time (Table) and are consistent with RA population reports.Overall AEs–314.6/100 PY(95% CI:311.5, 317.7); infections weremost frequent AE(103.7/100 PY, 95%CI:101.9, 105.5). Rate of AEsleading to withdrawal was 5.2/100 PY; most common AEs leading towithdrawal–laboratory abnormalities (1.1/100 PY),infections/infestations (1.0/100 PY), and neoplasms (0.7/100 PY).Overall SAEs–14.7/100 PY (95%CI:14.0, 15.4); infections were mostfrequent SAE (4.6/100 PY; 95%CI:4.3, 5.0). Rate of GIperforations–0.24/100 PY (95%CI:0.17, 0.37) is consistent withprevious reports. MI and stroke rates were, respectively, 0.3/100 PY(95%CI:0.2, 0.4) and 0.2 (95%CI:0.1, 0.3), stable over time and didnot exceed expected rates (MI, 0.4-0.8/100 PY; stroke, 0.5–0.9/100PY).3-5 Eight patients withdrew due to anaphylactic reactions. CONCLUSION: Rates of SAEs, SIs, and cardiovascular eventsremained stable with continued TCZ exposure in long-term OLclinical trials. These results demonstrate that the safety profile of TCZdoes not change with longer exposure. Event Rate/100 PY (95% CI) Over 12-Month Periods

0–12 13–24 25–36 37–48 AEs 418.4 297.9 273.3 251.4

(411.6, 425.2) (291.8, 304.1) (267.1, 279.6) (244.8, 258.0) SAEs 15.7 13.9 15.2 14.4

(14.4, 17.1) (12.6, 15.2) (13.7, 16.7) (12.8, 16.0) SIs 4.6 3.9 5.2 4.9

(3.9, 5.4) (3.2, 4.7) (4.3, 6.1) (4.0, 5.9) MI 0.3 0.2 0.3 0.5

(0.1, 0.5) (0.1, 0.4) (0.1, 0.6) (0.3, 0.9) Stroke 0.3 0.1 0.2 0.1

(0.1, 0.5) (0.0, 0.3) (0.1, 0.4) (0.0, 0.3)

Substance Abuse/Toxicology

257. Synuclein Gene Microsatellite Length Associated withAlcohol and Cocaine Addiction. Vanessa L. Herring, B.S.1, WesleyM. Pitts Jr., M.D.2, S. Casey Laizure, Pharm.D.1; (1)University ofTennessee, Dept of Clinical Pharmacy, Memphis, TN; (2)VeteranAffairs Medical Center, Memphis, TN PURPOSE: Alpha- is a highly expressed presynaptic protein that actsas a negative modulator of dopamine activity in the central nervoussystem. An allele-length variation in a microsatellite (NACP-Rep1) ofthe alpha- gene has been previously reported to be associated withalcoholism. Since dopamine is the primary neurotransmitter of thereward pathway that underlies all addictions, we hypothesized thatother addiction disorders would show genetic variation in the NACP-Rep1 microsatellite consistent with alcoholism. METHODS: This hypothesis was tested by comparing the NACP-Rep1 microsatellite allele lengths in three groups: 1 with alcoholism,2)cocaine addicted patients, and 3)a control group without evidence ofaddiction. All subjects (n=61) were male, African-American patientsfrom a Veteran Affairs Medical Center. Subjects underwent aninterview to assess drug use, evaluation of their medical records,completion of an AUDIT (Alcohol Use Disorders Identification Test),and blood sample collection. Subject DNA was isolated from blood,NACP-Rep1 sequence amplified, and allele-length determined byelectrophoresis. RESULTS: The table summarizes NACP-Rep1 base pair () allelelengths by group.

269-ContainingPairs Major PairAt least Frequency one 269 267/269 267/273

Group n Age (yrs) bp bp bp AUDIT Alcohol 25 55±8.7 56 % 30 % 0 % 28.6±6.4 Cocaine 18 55±6.2 61 % 22 % 6 % 8.2±9.2 Control 18 48±11.3 22 % 0 % 22 % 3.8±3.5The probability of being a carrier of at least one 269bp allele-lengthwas greater in the alcohol and cocaine groups when compared to thecontrol group (p=0.036; χ2 distribution). Also notable was the strikingdifference in the major pair frequency between the alcohol and controlgroups. CONCLUSION: The NACP-Rep1 allele length of 269 is associatedwith alcohol and cocaine addiction; a finding that is consistent with invitro alpha- expression studies and the dopamine deficiencyhypothesis of addiction.

Transplant/Immunology

258. Evaluation of a pre-emptive strategy for CMV diseaseprevention in cardiac transplant patients. Edward T. Horn,Pharm.D., BCPS1, Dana K. Reither, Pharm.D.2, Lauren King,Pharm.D.3, Stephen H. Bailey, M.D.1, Walter E. McGregor, M.D.1,Robert J. Moraca, M.D.1, George G. Sokos, D.O.1, Raymond L.Benza, M.D.1, Srinivas Murali, M.D.1; (1)Allegheny General Hospital,Pittsburgh, PA; (2)University of Pittsburgh School of Pharmacy,Pittsburgh, PA; (3)Mylan School of Pharmacy Duquesne University,Pittsburgh, PA PURPOSE: To determine the rate of cytomegalovirus (CMV)infection, based on serology, utilizing a modified pre-emptive antiviralstrategy. ISHLT guidelines recommend valganciclovir (VGC) for 3months in either D+/R- or D+/R+ patients. METHODS: Retrospective analysis of 39 OHTx patients fromFebruary 2008-July 2010 given either acyclovir (ACV) or VGC basedupon donor (D) and recipient (R) serology for 3 months post OHTx.CMV viremia was determined by polymerase chain reaction (PCR)with any value > 600 copies/ml deemed positive. CMV syndrome wasdefined as CMV viremia by PCR combined with fever, malaise,leukopenia, and/or thrombocytopenia. CMV tissue invasive diseasewas defined as end-organ infection with tissue diagnosis. Rejectionwas defined as any biopsy > ISHLT grade 2R. Standardimmunosuppression included basiliximab, tacrolimus, mycophenolate,and steroids. Logistic regression and c2 tests were used to determineassociations between risk factors and CMV disease occurance. Pre-Emptive CMV Prophylaxis Strategy (all therapy given for 3 months)


D+/R- VGC 900mg DailyD+/R+ ACV 400mg BIDD-/R+ ACV 400mg BIDD-/R- ACV 400mg BIDRESULTS: Of 39 OHTx, 37 had at least 30 days of follow-up. 11/37patients (29.7%) developed 12 cases of CMV viremia. Viremiafrequency rates were: CMV D+/R- 6/15 (40%); D+/R+ 3/12 (25%);D-/R+ 1/6; D-/R- 1/4. 83% of CMV D+/R- patients developed CMVviremia after prophylaxis expired. CMV viremia did not appear toimpact rejection rates between groups. Of the 12 cases of CMVviremia, 9 were asymptomatic (75%). 25% had CMV syndrome. Nocases of tissue invasive disease were reported. The only significantcorrelation was that VGC was shown by logistic regression to prolongthe time to viremia by 3 months (p=0.01). CONCLUSIONS: We feel that a pre-emptive strategy is effective toprevent CMV disease in OHTx patients. VGC could be extended to 6months in CMV D+/R- group. The use of VGC in other groups shouldbe researched further.

259. Corticosteroid withdrawal in renal transplant recipients: ananalysis of the Mycophenolic Acid Observational RenalTransplant Registry. Kimi Ueda Stevenson, Pharm.D., BCPS1, AnneWiland, Pharm.D., BCPS2, V. Ram Peddi, M.D.1; (1)California PacificMedical Center, San Francisco, CA; (2)Novartis PharmaceuticalCorporation, East Hanover, NJ PURPOSE: Corticosteroid withdrawal (CSW) protocols are desiredby renal transplant recipients to potentially reduce adverse effects(AEs). This analysis compared outcomes in patients who received CSto those who did not. METHODS: Using data from the Mycophenolic Acid ObservationalRenal Transplant registry, a prospective study of patients receivingmycophenolate (MPA) either as enteric-coated mycophenolate sodium(EC-MPS) or mycophenolate mofetil (MMF), 12-month CSWprotocol outcomes were analyzed. CSW was defined as withdrawal ofsteroids by 3-months post-transplant. RESULTS: A total of 847 tacrolimus-treated patients (352 CSW, 495CS) were included. Demographics were similar. More patients in theCSW group received depleting antibody induction (85.8%/ 63.3%).Tacrolimus trough levels were similar. Biopsy-proven acute rejections(BPAR) were low (9.6% CS/7.4% CSW, p=0.20). Interim results at 1,3, 6 and 12 months showed that significantly (p≤0.01) more of the CSpatients were maintained on full dose MPA (CS/CSW: 83.0/68.5%;73.1/52.6%; 58.4/37.6%; 51.3/36.1%). A significantly higherpercentage of CS patients treated with EC-MPS were maintained onfull MPA doses compared to MMF-treated patients. This was notobserved in the CSW group. There was a statistically significantdifference in graft survival (99.4/97.4%, p=0.02) favoring the CSWgroup. Patient survival was similar. The CS patients had a higher meanserum creatinine (CS 1.53/CSW 1.40 mg/dL, p=0.02) and there wereno differences in reported infections (including CMV and BK), bonedisease, diabetes, malignancies, cardiovascular or GI events. Morereported GI AEs occurred in the MMF-treated CSW patients (73.6%MMF/ 66.1% EC-MPS, p=0.15) and more hematological AEs in theCSW patients (61.4%/28.5%, p≤0.01), mainly driven by leukopenia. CONCLUSIONS: CS allowed for better tolerance of full dose MPA,however, there was no difference in BPAR. Graft survival was betterin the CSW group at 1 year, however, longer follow-up is needed toassess long-term outcomes of CSW.

260. Early analyses of renal transplant recipients who receivedexpanded criteria donor kidneys from the Mycophenolic AcidObservational Renal Transplant Registry. Kimi Ueda Stevenson,Pharm.D., BCPS1, Anne Wiland, Pharm.D., BCPS2, V. Ram Peddi,M.D.1; (1)California Pacific Medical Center, San Francisco, CA;(2)Novartis Pharmaceutical Corporation, East Hanover, NJ PURPOSE: The Mycophenolic Acid Observational Renal TransplantRegistry, a prospective study of patients receiving mycophenolic acid(MPA) therapy, is designed to determine effectiveness, tolerability andsafety of enteric-coated mycophenolate sodium (EC-MPS) versusmycophenolate mofetil (MMF) regimens. The objective of thisanalysis was to compare 12-month outcomes in patients who receivedexpanded criteria donor (ECD) kidneys to those who did not. METHODS: Based on local practices at 40 US sites, outcomes

analyzed included: graft survival, patient survival, first biopsy-provenacute rejection (BPAR), adverse events (AEs), serum creatinine andproportion of patients maintained on full MPA dose (1.44/2.0 g/day,EC-MPS/MMF). A total of 102 ECD (73 EC-MPS/29 MMF) and 832non-ECD (557 EC-MPS/275 MMF) patients were included. RESULTS: Donors (60.7/39.0 yrs, p≤0.01) and recipients (61.6/50.1yrs, p=0.03) were older in the ECD group. More African Americanpatients received ECD kidneys (32.3/ 23.6%, p=0.07). The majority ofpatients received induction therapy (99% ECD, 97% non-ECD),tacrolimus (97% ECD, 96% non-ECD) and steroids (69% ECD, 66%non-ECD) for maintenance therapy. At 1, 3, 6 and 12 months, morenon-ECD patients received full MPA doses (non-ECD/ ECD: 78.2/71.0%, p=0.12; 67.4/ 53.6%, p=0.01; 51.9/ 42.3%, p=0.14;45.7/41.0%, p=0.50). Comparable 12-month effectiveness, tolerabilityand safety outcomes were achieved in both groups whether theyreceived EC-MPS or MMF. Comparing 12-month outcomes in ECD tonon-ECD patients regardless of MPA type, BPAR (10.0/9.1%, p=0.91)and graft survival (94.5/97.5%, p=0.08) were similar whereas meanserum creatinine (1.75/1.46 mg/dL, p≤0.01) was higher in the ECDgroup. Patient survival was 98.8% in the ECD and 98.9% in the non-ECD patients. There were no differences in AEs (infections, diabetes,gastrointestinal, neoplasms, hematological) between the groups. CONCLUSION: Graft survival and BPAR were similar betweenECD and non-ECD patients. However, as expected, patients whoreceived ECD kidneys exhibited higher mean serum creatinines.

261. Comparisons of enteric-coated mycophenolate sodium andmycophenolate mofetil outcomes from the Mycophenolic AcidObservational Renal Transplant Registry. Ali Olyaei, Pharm.D.,BCPS1, Anne Wiland, Pharm.D., BCPS2, Lonnie Smith, Pharm.D.3;(1)Oregon State University/Oregon Health and Sciences University,Portland, OR; (2)Novartis Pharmaceutical Corporation, East Hanover,NJ; (3)University of Utah Hospitals and Clinics, Salt Lake City, UT PURPOSE: The Mycophenolic Acid Observational Renal TransplantRegistry is a prospective study of de novo renal transplant patientsreceiving mycophenolic acid (MPA) therapy designed to determineeffectiveness, tolerability and safety of enteric-coated mycophenolatesodium (EC-MPS) versus mycophenolate mofetil (MMF)-basedimmunosuppressive regimens. METHODS: Based on standard-of-care at 40 centers, outcomesanalyzed included: graft survival, patient survival, first biopsy-provenacute rejection (BPAR), mean serum creatinine, adverse event (AE)rates, and percentages of patients maintained on full MPA dose (1440or 2000 mg/day, EC-MPS or MMF respectively). Preliminary datafrom 901 patients (age 51.5, 64% male, 43% living donor transplantrecipients) receiving tacrolimus were analyzed. RESULTS: Interim results at 1, 3, 6 and 12 months from 613 EC-MPS and 288 MMF patients showed that more EC-MPS patients weremaintained on full doses of MPA (ECMPS/MMF: 79.2/71.2%, p=0.01;68.6/55.6%, p<0.01; 52.7/43.0%, p=0.02; 47.3/39.4%, p=0.08). Actualmean MPA doses (SD) standardized to MMF dosing for EC-MPS/MMF were: 1853 (378) mg v. 1789 (441) mg, p=0.04; 1753(465) mg v. 1648 (493) mg, p<0.01; 1590 (521) mg v. 1494 (529) mg,p=0.03; and 1532 (511) mg v. 1453 (522) mg, p=0.08 at months 1, 3, 6and 12 post-transplant. Comparable 12-month clinical outcomes wereachieved for effectiveness outcomes, tolerability and safety for bothEC-MPS and MMF. There were no significant differences betweenEC-MPS and MMF-treated renal transplant recipients in graft survival(96.9/97.6%, p=0.48), patient survival (99.3/98.4%, p=0.31), BPAR(9.6/8.0%, p=0.30), mean serum creatinine (1.49/1.49 mg/dL, p=0.97)or cumulative incidence of early AEs by organ system, infections orneoplasia. CONCLUSION: These results show that the majority of renaltransplant recipients who received tacrolimus as maintenanceimmunosuppression are maintained on full doses of MPA early post-transplant. Early significant dosing differences are seen between EC-MPS and MMF which may impact outcomes at later time points inthis study.

262. African American renal transplant one year outcomes fromthe Mycophenolic Acid Observational Renal Transplant Registry.Lonnie Smith, Pharm.D.1, Anne Wiland, Pharm.D., BCPS2, Ali Olyaei,Pharm.D., BCPS3; (1)University of Utah Hospitals and Clinics, Salt

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Lake City, UT; (2)Novartis Pharmaceutical Corporation, EastHanover, NJ; (3)Oregon State University/Oregon Health and SciencesUniversity, Portland, OR PURPOSE: The Mycophenolic Acid Observational Renal Transplant(MORE) Registry, a prospective study of renal transplant recipientsreceiving mycophenolic acid (MPA) therapy, is designed to determineeffectiveness, tolerability and safety of enteric-coated mycophenolatesodium (EC-MPS) vs mycophenolate mofetil (MMF) regimens. Thisanalysis of the MORE registry compares outcomes of AfricanAmerican (AA) to non-AA patients. METHODS: Based on local practices at 40 centers, outcomesanalyzed included: graft survival, patient survival, first biopsy-provenacute rejection (BPAR), adverse events (AEs), serum creatinine andproportion of patients maintained on full MPA dose (1.44/2.0 g/day,EC-MPS/MMF). A total of 217 AA (149 EC-MPS/68 MMF) and 684non-AA (464 EC-MPS/220 MMF) tacrolimus-treated patients wereincluded. RESULTS: AAs were less likely to receive a living donor (24/49%)and more likely to experience delayed graft function (21/14%) thannon-AAs. At 1, 3, 6 and 12 months, more AA EC-MPS patientsreceived full MPA dose (EC-MPS/MMF: 82.2/70.8%, p=0.07; 65.0/54.8%, p=0.21; 55.2/36.0%, p=0.05; 45.0/41.5%, p=0.71).Comparable 12-month effectiveness, tolerability and safety outcomeswere achieved in both groups. Comparing EC-MPS to MMF in theAAs, there was similar graft survival (94.5/97.9%, p=0.58), BPAR(14.5/13.1%, p=0.75), mean serum creatinine (1.67/1.74 mg/dL,p=0.77) and reported AEs by organ system, infections or neoplasia.Patient survival (99.2/96.5%, p=0.04) was higher in the AA EC-MPSgroup. Similar outcomes were observed between EC-MPS and MMFin the non-AAs. Comparing 12-month outcomes in AA to non-AApatients regardless of MPA type, BPAR (14.1/7.5%, p=0.01), graftsurvival (95.5/97.7%, p=0.07) and serum creatinine (1.67/1.43 mg/dL,p<0.01) were worse in the AA patients whereas patient survival(98.3/99.2%, p=0.69) was similar. CONCLUSION: More AA patients treated with EC-MPS weremaintained on full doses of MPA. Despite this, AAs exhibited higherBPAR, serum creatinine and worse graft survival than non-AAs whichmay impact clinical outcomes at later timepoints in this study.

263E. Steroid-free, calcineurin inhibitor minimizing regimen withlong-term mycophenolate mofetil monotherapy for HLA identicalliving donor kidney transplantation: long-term outcomes. Adele R.Shields, Pharm.D.1, Rita R. Alloway, Pharm.D.1, Amit Govil, M.D.1,Gautham Mogilishetty, M.D.1, Michael Cardi, M.D.2, Shahzad Safdar,M.D.2, Shaoming Huang, M.D.2, E. Steve Woodle, M.D.1;(1)University of Cincinnati, Cincinnati, OH; (2)The Christ Hospital,Cincinnati, OH PURPOSE: This study evaluated a corticosteroid-free, calcineurininhibitor (CNI) minimizing, short-term SRL (SRL) regimen with long-term mycophenolate mofetil (MMF) monotherapy in HLA-identicalliving donor kidney transplant patients. METHODS: Data from 36 HLA-identical transplant patients from2002–2010 was prospectively collected. 2 consectutive patient cohortswere evaluated. 20 patients received tacrolimus (TAC) (target trough4–8 ng/ml), SRL (target trough 6-10 ng/ml), and MMF (2 gm/day)started 2 days pretransplant. The next 16 patients received MMFstarting 1 week pretransplant, SRL on day of transplant and TACposttransplant day (PTD) 1. If no acute rejection (AR) from PTD60–90, TAC dose was reduced 50% and discontinued by PTD 90–120.Corticosteroids were not given. If no AR by PTD 300, SRL wastapered off over 2 months leaving MMF monotherapy. AR diagnosedby Banff97 biopsy criteria. RESULTS: Demographics and outcomes are in the table. 100% ofpatients (12/12) who reached 5 years posttransplant were maintainedon MMF monotherapy. Primary reason for not being withdrawn fromTAC was SRL or MMF intolerability. 4 patients (11%) requiredpremature SRL discontinuation due to intolerability. There was noCMV disease, PTLD, malignancy, or BK nephropathy. Overall pt anddeath-censored graft survival are 94.4%. 2 graft losses (5.6%) weredue to AR and chronic allograft nephropathy (CAN). One death wasWest-Nile viral meningoencephalitis on PTD 261 and one death wasunexplained sudden death on PTD 163.

Demographics and Outcomes Median Follow-up(days) 1738 (153-3197) Mean Age(years) 45.1 ± 9.8 Female 36% Repeat transplant 3% Pretxp DM 39% Mean Class 1 Peak PRA% 11.8 ± 25.5 Mean Class 2 Peak PRA% 9.5 ±22.1 Mean Time to DC-Graft Loss(days) 660.5 ± 95.5 CMV Viremia 3.8% CAN 5.6% CNI toxicity 5.6%CONCLUSION: A corticosteroid-free, CNI-sparingimmunosuppressive regimen with eventual weaning to MMFmonotherapy provides excellent patient survival, graft survival, andrenal function with minimal posttransplant complications in HLA-identical kidney transplant recipients. Presented at The American Transplant Congress, Philadelphia,Pennsylvania, May 1–4, 2011.

264. A prospective, single center, pilot study of pretransplantthymoglobulin administration and early corticosteroid withdrawalin living donor renal transplant recipients. Adele R. Shields,Pharm.D.1, Rita R. Alloway, Pharm.D.1, Michael Cardi, M.D.2,Shahzad Safdar, M.D.2, Shaoming Huang, M.D.2, Paul Brailey, Ph.D.1,Alin Girnita, Ph.D.1, Rino Munda, M.D.1, Tonya Dorst, M.A.1, E.Steve Woodle, M.D.1; (1)University of Cincinnati, Cincinnati, OH;(2)The Christ Hospital, Cincinnati, OH PURPOSE: Rabbit anti-thymocyte globulin (rATG), is widely used inrenal transplant patients for induction. However, its use in a pretransplantregimen has not been evaluated. The purpose was to evaluate safety andeffectiveness of rATG starting 4 days prior to transplant. METHODS: This was an IRB approved, prospective, pilot feasibilitystudy. Patients were eligible if they received a primary non-HLAidentical living donor transpalnt. Patients received tacrolimus (10–15ng/mL) and MMF at time of transplant. Methylprednisolone wasgiven as premedication (500 mg with 1st dose, 250 mg withsubsequent 2 doses, 125 mg with 4th dose). Group 1 received 4 dosesat 1.5 mg/kg/day on Days -4, -2, 0, and 2. Group 2 received 3 doses at1.5 mg/kg/day on Days -4 and -2, and 3 mg/kg on Day 0. RESULTS: 11 patients were enrolled. Demographics and outcomesare in Table 1. Infusion-related toxicities are in Table 2. Patient andgraft survival are 100% at 6 months and 1 year. 2 patients had an acuterejection.

Demographics/Outcomes Group 1 (n=6) Group 2 (n=5) p

Mean # rATG 4 ± 0 3.2 ± 0.4 NS Mean mg/kg rATG 5.8 ±0.7 5.6 ±0.9 NS Age 50.1 ±17.1 36.1 ±12.5 NS Female 16.7% 40% NS AA 0 40% NS Acute Rejection 16.7% 20% NS Mean Scr Day30 1.6 ±0.6 1.5 ±0.7 NS

Day180 1.5 ±0.7 1.7 ±0.3 NS Mean CD3 Day -4 1063.5 ±754.5 942.5 ±181.6 NS

Day -2 51.2 ±79 143 ±130.1 NS Day 0 18.2 ±29.7 113 ±95.1 0.04 Day 1 2 ±1.0 4.3 ±4.2 NS Day 2 4.5 ±5.2 8.3 ±11 NS Day 3 3 ±0 44 ±69.3 NS Day 4 4.8 ±3.8 43.3 ±72 NS

Toxicities Fever/Chills 64% HTN 18% Admit Observation 18% Body-aches 18% Nausea/vomiting 9% WBC < 2000 cells 0 PLT < 100,000 cells 18%CONCLUSION: rATG administration prior to txp is well toleratedand effective. These preliminary results support further study of pretxprATG in a larger population.


265. Pepper mould contamination risk to immunocompromised.John D. Cleary, Pharm.D.1, Jessica Robinson, Pharm.D.2;(1)University of Mississippi Medical Center, Jackson, MS;(2)University of Charleston School of Pharmacy, Charleston, WV PURPOSE: Aeresolization of pepper in an immunocompromisedpatient’s inhalation space could increase risk for mould infection. Ourpurpose was to assess potential infection risk from contamination ofthis food product. METHODS: Pepper samples were purchased from retail settings overa 3 year period. Pre-culture preparation included: weighing 1 gpepper; normal saline suspension 5mL containing penicillin/streptomycin and vancomycin; 30 second vortexing; then 30 minutegravity separation. Culture Preparation involved preparing 3 serial1:10 dilutions, plating 0.1 mL supernatant on a Sabhi agar dish induplicate. These studies were performed in triplicate. Cultures wereincubated at 30°C for up to 14 days with daily monitoring. Cultureswere identified & counted using routine staining under microscopy.Galactomannan testing was performed on samples using the Platelia™Aspergillus EIA test. RESULTS: A total of 95 black pepper samples were collected from23 states and 33 cities across the United States and 6 non-US sites.Samples included ground pepper and/or peppercorn. Positive samples(N=18; 20.9% of total) were more frequent in samples from Southern(61.1% of positives) compared to Western (22.2%), Midwestern(11.1%), & Northern (5.6%) states. International (N=9) was observedto have 33% positive. Analysis of positive samples by manufacturesrevealed that national brand name products (26.7%) were lesscommon compared to local brands (58.6%). Sterilization (ethyleneoxide) processes were used more frequently in national brands(86.7%) compared to local brands (3.4%) in positive samples.Organisms isolated include Aspergillus and Rhizopus species. Allculture positive samples identifiable via galactomannan testing. CONCLUSION: Patients receiving immune modulators (i.e., TNFinhibitors) and common immune-suppressants are not routinelywarned of this risk and should be educated by the pharmacist to avoidpepper. Our plan is to genotype fungal isolates and compare withisolates identified in patients with invasive disease in attempts tofurther elucidate infection risk.

266. Use of HMG-CoA reductase inhibitors in liver transplantpatients with recurrent Hepatitis C Virus. Sarah E. Yost,Pharm.D.1, Heather J. Johnson, Pharm.D.2, Kristine S. Schonder,Pharm.D.3, Michael DeVera, M.D.4, Kapil B. Chopra, M.D.5;(1)University Medical Center, Tucson, AZ; (2)UPMC Department ofPharmacy and Therapeutics, Pittsburgh, PA; (3)University ofPittsburgh School of Pharmacy, Pittsburgh, PA; (4)Loma LindaUniversity Transplantation Institute, Loma Linda, CA; (5)Universityof Pittsburgh Medical Center, Division of Gastroenterology,Hepatology, and Nutrition, Pittsburgh, PA PURPOSE: The aim of this study was to evaluate the antiviralsuppressing effects and safety of statins in patients with Hepatitis CVirus (HCV) recurrence after liver transplantation. METHODS: A retrospective cohort study of patients with HCV thatreceived a liver transplant and statin therapy following documentedHCV recurrence were included. The area under the HCV viral loadcurve (AUC) was determined. Aspartate aminotransferase (AST),alanine aminotransferase (ALT), and total bilirubin were evaluated atthe time of statin initiation and 3, 6, and 12 months post statininitiation. RESULTS: Twenty nine patients with HCV recurrence after livertransplantation were started on statin therapy after HCV recurrence.Of these patients, only ten patients were included for AUC analysis.The mean atorvastatin equivalent dose was 15.4 mg ± 9.2 mg. Themean time from transplant to start of statin therapy was 1316.2 days ±1029.3 days (range 162 to 3824 days). The majority of patients (92%)were at goal at statin initiation, with a total cholesterol less than 200mg/dl. The majority of the AUC HCV viral load per time in daysremained at baseline or decreased over time. No significant changesfrom baseline in aminotransaminases and total bilirubin were seenpost statin initiation. CONCLUSION: Use of statins in liver transplant patients with HCVrecurrence did not appear to negatively affect the HCV viral load.Statins did not appear to significantly increase aminotransaminases

and total bilirubin and can be used safely in liver transplant patientswith HCV recurrence.

267. Impact of rituximab on donor specific antibody burden insolid organ transplant recipients. Dina Benani, Pharm.D., AngelaBingham, Pharm.D., Rachel Kruer, Pharm.D., Liana Mark, Pharm.D.,Laura Lees, Pharm.D., Kenneth Shermock, Pharm.D., Ph.D., LindseyLombardi Thomas, Pharm.D., Christopher R. Ensor, Pharm.D.; TheJohns Hopkins Hospital, Baltimore, MD PURPOSE: Rituximab results in the selective depletion ofcirculating, non-splenically-sequestered, CD-20 expressing B-lymphocytes (CD20BL) and has been associated with down-regulationof donor-specific antibody (DSA) burden in solid organ transplantrecipients (SOTR). Thus, we performed a retrospective single-centerstudy to characterize the impact of rituximab on DSA burden inSOTRs. METHODS: Medical records of 104 adult SOTRs who receivedrituximab from January 1, 2005 to February 28, 2010 were reviewed.We assessed the percentage of circulating CD20BLs at day three post-rituximab and absolute lymphocyte count (ALC) for seven post-dosedays. DSA mean fluorescent intensity by solid phase assay wasevaluated and characterized qualitatively based on its propensity toyield a positive crossmatch either by flow cytometry or complement-dependent cytotoxicity immediately prior to rituximab administration,within the first 14 post-dose days, and at post-dose days 30, 60, 90,120, and 180. RESULTS: Recipients of kidney (n=99), lung (n=4), and heart (n=1)transplants were included. Mean age was 44 (SD 14) years, 61% male;many patients received concomitant intravenous-immunoglobulins(70%) or plasmapheresis (79%). 138 dose-occurrences of rituximab375mg/m2 were administered to 104 patients; for which 117occurrences had DSA data available. CD20BL depletion to <1%occurred after 94% of occurrences, and median ALC fell from 605(IQR 200-1405)/mm3 to 200 (IQR 69-510)/mm3. In occurrences wherethe baseline crossmatch was positive (n=91/117), 28% (n=26/91)experienced substantial DSA depletion to yield a negative crossmatch.Of these, 19% (n=5/26) later developed recurrent positivity. Inoccurrences where the baseline crossmatch was negative (n=26/117),89% (n=23/26) remained persistently negative, while 11% (n=3/26)developed positivity. CONCLUSIONS: Rituximab effectively depleted CD20BLs andALCs in study SOTRs. Despite this, only 28% developed therapeuticDSA depletion. Conversion from a negative to positive crossmatchwas suppressed in 89% of occurrences after rituximab. We believeprospective evaluation of rituximab use in SOTRs is warranted.

268E. Comparison of calcineurin inhibitor administration post-heart transplantation. Cory Blacksmith, Pharm.D., Jodie M. Fink,Pharm.D., BCPS; Cleveland Clinic Foundation, Cleveland, OH PURPOSE: The Cleveland Clinic heart transplant protocol wasrecently revised to recommend oral, rather than intravenous,calcineurin inhibitor (CNI) therapy in adult heart transplant recipientspost-operatively. The protocol was changed in January 2010 due to aconcern that intravenous administration of CNIs may contribute topost-operative nephrotoxicity. Thus, the evaluation of the safety andefficacy of the revised protocol comparing the immediate post-operative administration of oral vs. intravenous CNIs in adult hearttransplant recipients was performed. METHODS: A non-interventional, retrospective medical recordreview to evaluate adult (≥18 years old) heart transplant recipientsreceiving CNI therapy immediately post-operative from January 1,2008 to February 28, 2011 for the median change in serum creatinine(SCr) post-transplantation. Secondary endpoints include time (days) toreach target trough level, episodes of rejection within the first threemonths of transplant, and time (days) CNI therapy was held. Hearttransplant recipients who received induction therapy (i.e.,thymoglobulin or basiliximab) or everolimus will be excluded. Datadescribing demographics, renal function, rejection episodes, andimmunosuppression dosing and monitoring will be collected. RESULTS: Fifty-one patients were enrolled in the intravenous groupand 22 patients in the oral group. No difference in baselinedemographics was noted. Median change in SCr post-transplantationwas 0.39 mg/dL vs. 0.44 mg/dL, percentage of patients and median

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time CNI therapy held post-operatively was 22% (1.75 days) vs. 27%(1.25 days), median time to reach target trough level was 9.5 days vs.9.5 days, and percentage of patients with episodes of rejection was27.4% vs. 19.0% in the intravenous and oral groups, respectively. CONCLUSION: A similar safety and efficacy profile was seenbetween the post-operative administration of oral vs. intravenous CNItherapy. Based on these results, the protocol revisions will continuedto be used due to the ease of administration. Presented at Spring 2011 Pharmacotherapy Update of the OhioCollege of Clinical Pharmacy, Warrensville Heights, OH, May 23,2011.

269. Cardiovascular events and CV-related mortality after renaltransplantation: effect of maintenance steroid therapy andpreexisting coronary artery disease. Adele R. Shields, Pharm.D.1,Nicole M. Schmidt, Pharm.D.1, Rita R. Alloway, Pharm.D.1, MichaelCardi, M.D.2, Amit Govil, M.D.3, Dennis Hanseman, M.S.1, E. SteveWoodle, M.D.1; (1)University of Cincinnati, Cincinnati, OH; (2)TheChrist Hospital, Cincinnati, OH; (3)The Health Alliance, Cincinnati,OH PURPOSE: Early corticosteroid withdrawal (ECSWD) reducescardiovascular (CV) risk, however long term studies translating CVrisk reduction into CV events (CVE) have not been conducted. Thepurpose of this study was to compare actual CVE for ECSWD andchronic corticosteroid (CCS) maintenance therapy, as well asdetermining the impact of preexisting coronary artery disease (CAD). METHODS: Prospective CVE data was collected and entered into anelectronic database in 1004 renal transplant patients. 714 patientsreceived ECSWD and 290 patients received CCS regimens from1998-2010. CVE were defined as sudden death/CV-related death,myocardial infarction, angina/unstable angina, CVA/TIA, or CVprocedure. Statistical analyses included Chi square, student t-test, andKaplan-Meier (KM) using log rank. RESULTS: Demographics and patient outcomes are in the table. 267CVE occurred in 171 patients [100 ECSWD patients (14%) vs 71 CCSpatients (24.5%), p=0.0001]. Mean corticosteroid dose in the CCSgroup was 6.9±5.5mg at 1 year and 5±1.6mg at 4 years. KM analysisdemonstrated lower CVE rates with ECSWD (p<0.02). CV-relatedmortality (p=0.78) and overall pt mortality (p=0.54) however were notdifferent. Additional KM analysis showed that the difference in CVErates between ECSWD and CCS was primarily observed in patientswithout preexisting CAD (p=0.004).

ECSWD (n=714) CCS (n=290) p Mean follow-up (days) 1560.3 ± 1007.9 2217.4 ± 1465.6 <0.0001 Mean age (years) 49.3 ± 13.4 47.5 ± 12.4 0.05 Female 272 (38.1%) 133 (45.9%) 0.02 African American 146 (20.4%) 81 (27.9%) 0.01 Repeat transplant 68 (9.5%) 42 (14.5%) 0.02 Pre-transplant DM 216 (30.3%) 76 (26.2%) 0.19 Pre-transplant CAD 112 (15.7%) 33 (11.4%) 0.08CONCLUSION: Kidney transplant patients who undergo ECSWDhave a significantly higher CVE-free survival by KM despite havingmore CAD pretransplant. The benefit in CVE reduction seen withECSWD is primarily in patients without pre-existing CAD. Thedecrease in CVE does not become apparent until 3 to 4 yearsposttransplant.

270. Impact of immunosuppressant regimen on the onset ofhyperlipidemia in kidney transplant recipients. Shelby L. Corman,Pharm.D., M.S., BCPS, Kristine S. Schonder, Pharm.D.; University ofPittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: Various immunosuppressive agents have been associatedwith hyperlipidemia. We sought to explore whether steroid-freetacrolimus-based regimens affect the time to development ofhyperlipidemia after kidney transplant. METHODS: This retrospective cohort study included patients whounderwent a first kidney transplant between January 1996 andDecember 2009. Patients who had hyperlipidemia or were takingcholesterol-lowering medications at baseline were excluded. Patientswere separated into four groups according to their baselineimmunosuppressant regimen: tacrolimus monotherapy (group 1), dualtherapy with tacrolimus and mycophenolate mofetil (group 2), tripletherapy with tacrolimus, mycophenolate mofetil, and prednisone

(group 3), and dual therapy with tacrolimus and prednisone (group 4).Patients receiving other regimens were excluded. The primaryoutcome was the time to development of hyperlipidemia, defined as atotal cholesterol ≥200 mg/dl, low-density lipoprotein (LDL) ≥130mg/dl (≥100 mg/dl for patients with diabetes), or triglycerides ≥150mg/dl and/or initiation of cholesterol-lowering medications. RESULTS: A total of 1912 patients received a kidney transplantduring the study period. Of these, 919 were excluded due to baselineuse of cholesterol-lowering medications (n=491), baselinehyperlipidemia (n=192), previous transplant (n=107), use of otherimmunosuppressant regimens (n=79), or missing laboratory ormedication records (n=50). A Kaplan-Meier analysis showed that timeto hyperlipidemia did not differ significantly between the groups(p=0.193). Group n Days to hyperlipidemia 1 631 33.3 2 178 36.0 3 104 40.4 4 80 50.3A Cox proportional hazards model including study group, age, sex,race, and diagnosis of diabetes as covariates showed that only femalesex (HR=1.27; p<0.001) and white race (HR=1.30; p=0.003) weresignificant predictors of hyperlipidemia. CONCLUSION: Steroid-free immunosuppressive regimens did notreduce the time to onset of hyperlipidemia after kidney transplant.

271. A single center experience with conversion between twogeneric tacrolimus formulations. Eric Tichy, Pharm.D., BCPS1, LisaM. McDevitt, Pharm.D., BCPS2; (1)Yale-New Haven Hospital, NewHaven, CT; (2)Massachusetts College of Pharmacy and HealthSciences, Boston, MA PURPOSE: The first generic tacrolimus product gained Food andDrug Administration (FDA) approval in August 2009 and as of June2011 there are four generic formulations available in the US market.Reports of conversion between brand tacrolimus and SandozTM

generic tacrolimus have previously demonstrated the safety of brandto SandozTM generic conversion. This prospective, observational trialsought to determine the need for dose titrations upon conversionbetween two generic tacrolimus formulations. METHODS: Transplant recipients on stable tacrolimus doses wereconverted from SandozTM tacrolimus to MylanTM tacrolimus on amg:mg basis. Data were collected at the time of conversion (studyarm) and at a time point exactly 6 months prior to conversion (controlarm) for all subjects. RESULTS: Ten conversions from a single center are reported.Subjects were a mean of 37.1 months post kidney (n=9) or liver (n=1)transplant. In the study arm, mean tacrolimus doses were 6.8 mg/dayand 6.8 mg/day (p=NS) and mean tacrolimus trough concentrationswere 5.9 and 5.1 ng/ml (p=0.24) before and after conversion,respectively. In the control arm, mean tacrolimus doses were 7 and 6.8mg/day (p=0.34) and mean tacrolimus trough concentrations were 6.3and 6.4 ng/ml (p=0.8) before and after the control time point,respectively. Dose titrations occurred in 1 patient (10%) in the controlarm and 0 patients in the study arm. CONCLUSION: These data show that dose requirements and troughlevels are similar between two generic tacrolimus formulations.However, the strength of these conclusions are limited by the smallsample size.

272. Is valganciclovir a viable option for cytomegalovirus (CMV)prophylaxis in liver transplantation?Gregory Smallwood, B.S., Pharm.D.; PCOM School of Pharmacy,Suwanee, GA PURPOSE: Currently valganciclovir is approved for CMVprevention in both cardiac and kidney transplantation. In the pivotalPV16000 registration trial, liver transplant recipients had an increasein tissue invasive CMV disease and did not receive FDA approval.However, many liver transplant centers use valganciclovir for CMVprophylaxis. The aim of the project is to compare the frequency ofCMV viremia as determined by polymerase chain reaction(PCR)between liver transplant patients being followed with a preemptivestrategy and treatment compared to patients taking valganciclovir for100 days as prophylaxis.


METHODS: This is an IRB approved review of patients beingfollowed for CMV. Patients were routinely followed by weekly, serialblood draws for CMV by polymerase chain reaction (PCR). Based ontime transplanted, patients received valganciclovir prophylaxis of900mg daily or monitored by PCR as a preemptive approach. Theprophylaxis group(Pro) was compared to the pre-emptive(Pre) groupfor outcomes as determined by CMV viremia. RESULTS: From Jan. 1, 2003, 309 consecutive liver transplantrecipients were followed for CMV viremia. The two groups weresimilar in respect to demographics and primary disease(p=0.742).Seroconversion was documented in 108 (34.9%) by PCR for CMVwith similar conversion rates by group(36.4% vs. 33%; p=0.562). ThePre group had higher rate of CMV at 3 months when compared to thePro group[28/150(28.9%) vs. 6/150(4%): p=0.001]. The Pre group hadshorter time to CMV(66 days vs. 158 days; p=0.001) but similar ratesof rejections(p=0.899) and difference in MELD scores(21 vs. 23;p=0.002). CMV Disease free survival were similar between groups at1 year (68.5% vs. 61.6%; p=0.936). There were slightly moremismatched organs in the Pro group (11/159 vs. 33/150; p=0.005). CONCLUSION: Valganciclovir prophylaxis in liver transplant doesnot prevent CMV viremia(p=0.562), only the time toviremia(p=0.001). Continued work in CMV is required to preventCMV viremia in liver transplantation.

Women’s Health

273. Low molecular weight heparin use in the pregnantpopulation. Kylie N. Barnes, Pharm.D.1, Alicia B. Forinash,Pharm.D., BCPS2, Laurie Niewoehner, Pharm.D.3, JeffreyGreenspoon, M.D.4; (1)St Louis College of Pharmacy, St Louis, MO;(2)St. Louis College of Pharmacy, Saint Louis, MO; (3)St. Mary’sHealth Center, St Louis, MO; (4)Saint Louis University, St Louis, MO PURPOSE: Low molecular weight heparin (LMWH) is dosed basedupon two determining factors: patient’s weight and renal function.During pregnancy, both renal function and weight increase throughoutall three trimesters, which indicatess a need for anti-Xa levels to bechecked throughout the pregnancy to ensure levels are dosed highenough to accommodate for these changes. The CHEST guidelinesindicate LMWH is appropriate for anticoagulation management duringpregnancy and recommend LMWH doses be adjusted to achieve atherapeutic anti-Xa level (0.5–1.2 units/mL). However, the CHESTguidelines do not indicate a clear method or time frame for checkinganti-Xa levels during pregnancy. The purpose of this study is todetermine if pregnant patients in the high-risk OB/GYN (HROB)clinic at St. Mary’s Outpatient clinic are receiving therapeutic startingdoses of LMWH based on anti-Xa levels. METHODS: Retrospective data collection through chart review usingapplicable ICD-9 codes identified patients receiving enoxaparinduring pregnancy. Demographic information, indication for LMWH,enoxaparin dose, and frequency, anti-Xa levels, therapeutic changesbased on levels, time to receive lab results, and time from receivinglab to changes were analyzed. RESULTS: A total of 12 pregnant women were included in the studyand were treated with LMWH at therapeutic doses. Only five patientshad an anti-Xa level checked during their pregnancy; two of thepatients’ initial levels were therapeutic, and the other three weresubtherapeutic. Time to first anti-Xa lab had a wide range (1 day tonever checked). Initial dosing was 0.8–1.2 mg/kg/d divided for themajority of patients. CONCLUSIONS: Significant gaps were identified in the currentprocess of LMWH dosing in the pregnant population at St. Mary’sHROB clinic. Increased education is needed to improve awarenessand overall patient care. A need for pharmacy intervention withmonitoring and proactive treatment approach was identified and isbeing addressed.

CLINICAL PHARMACY FORUM

Adult Medicine

274. Evaluation of medication reconciliation for inpatients withuncontrolled diabetes: preimplementation study. Charlene A.Hope, Pharm.D., BCPS; Norwegian American Hospital, Chicago, IL PURPOSE: To evaluate accuracy of medication reconciliation of the

diabetic regimens of patient admitted to adult medical-surgical nursingunits. To identify drug-related problems associated with the regimenand potential for advancing patient’s therapeutic regimen to goal (forexample: titrating to max doses of oral therapy and/or initiating homeinsulin regimen). METHODS: A retrospective chart review over a three month periodwas performed. Adult patients admitted to a medical-surgical nursingwith a documented Hemoglobin A1C > 9 were classified as havinguncontrolled diabetes and charts were selected for review. AdmissionMedication Reconciliation forms were reviewed and patient’s homediabetes therapeutic regimens were documented and reviewed forpotential drug related problems and opportunities to adjust theirtherapeutic regimen to achieve target A1C levels. Data collected fromthis study will be used as baseline data prior to implementation of amulti-disciplinary Diabetes Care Team. RESULTS: A total of 34 medical charts were reviewed. Three (3)charts did not have discharge medication reconciliation forms andcould not be utilized. Twenty-six (26) % (8/31) of the patient diabetesregimens reviewed revealed that there was no change in their regimenwhile admitted as an inpatient. Twelve (39%) did reveal a change inthe patients drug regimen; such changes included increasing theinsulin dosages or changing from a mixed-insulin to a basal-bolusinsulin regimen. A little over 1/3 of the patients did not know theirdiabetes medication regimen or did had no medications documentedon their medication reconciliation form. The average A1C of the studygroup was 11.3 (9.3–14). CONCLUSION: There are several opportunities for clinicalpharmacist to get involved to improve patient outcomes for thispatient population. There were two that could have the most impact onimproving quality of care include: 1) Participating in obtainingmedication histories for these patients on admission. 2) Providingtherapeutic recommendations to physicians to advance drug therapy tomaximize A1C lowering.

275. Evaluation of a diabetic ketoacidosis protocol to improvequality and cost of care. Nishil P. Patel, Pharm.D., BCPS, SumaDronavalli, M.D., Ishaq Lat, Pharm.D., BCPS; University of ChicagoMedical Center, Chicago, IL PURPOSE: This retrospective review was conducted to identify areasfor improvement in the treatment of diabetic ketoacidosis. METHODS: A drug utilization report was used to identify patientsadmitted with diabetic ketoacidosis (DKA) during January 2011.Fifteen patients were identified and retrospectively evaluated to assessthe utilization and adherence to the hospital’s DKA protocol.Additional data collected to determine quality and cost of careincluded: hypoglycemic events, total hours of insulin infusion, insulininfusion titration, reinitiation of insulin infusion, transition fromintravenous to subcutaneous (SC) insulin, and serum ketones. RESULTS: Of the 15 encounters, 10 (66%) patients were initiated onthe correct protocol, but there was 0% adherence to the insulininfusion titration protocol. A total of 54 hypoglycemic events (bloodglucose < 70 mg/dl) were documented, and 66% of the patientsreviewed had at least one hypoglycemic event. The average time apatient remained on an insulin infusion varied by nursing unit; patientsin the ED remained on insulin infusion for a mean time of 12.2 ± 8.8hours compared to a mean of 20.75 ± 17.2 hours for patients on amedicine unit. Additionally, 46% of patients met the criteria forresolution of DKA at the cessation of insulin infusion, but only 25% ofpatients were properly overlapped with SC insulin. Six (40%) of thecases reviewed had insulin infusion therapy re-initiated. Lastly, 10 of16 (62.5%) patients had a high frequency of serial serum ketonesordered which contributed to additional and unnecessary lab costs. CONCLUSION: Retrospective analysis easily identified specificareas of quality and practice improvement.

276. Argatroban dosing evaluation amongst medical patients in acommunity hospital. Janene L. Marshall, Pharm.D.1, Jorge Berrios,Pharm.D.2, Rita Magnuson, Pharm.D.3; (1)Chicago State UniversityCollege of Pharmacy, Chicago, IL; (2)Cardinal Health, Houston, TX;(3)Little Company of Mary Hospital and Health Care Centers,Evergreen Park, IL PURPOSE: To compare patients that received argatroban dosed eitherby the physician or by pharmacy protocol with patients receiving

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argatroban dosed with a revised protocol in order to determine if thetime to achieve a therapeutic activated partial thromboplastin time(aPTT) and conversion to warfarin therapy could be decreased. METHODS: A retrospective chart review was performed from July-December 2009 of all adult inpatients that received argatroban therapyfor heparin induced thrombocytopenia (HIT) or heparin inducedthrombocytopenia thrombosis syndrome (HITTS). The diagnoses,medical histories, laboratory values, and medication administrationrecord data were documented. After evaluation, the argatrobanpharmacy dosing protocol was revised. A prospective chart reviewwas performed from September 2010-Feburary 2011. RESULTS: In the retrospective chart review, patients achieved amean therapeutic aPTT (SD) in 16.2 (26.2) hours and received a meanduration of 6.7 (6.4) days of therapy. Ten patients (66.7%) wereconverted to warfarin with 30% achieving a therapeutic INR in a meanof 5.3 (2.1) days. Two patients (13.3%) had a significant adverse drugreaction requiring a blood transfusion. In the prospective review,patients achieved a therapeutic aPTT in 6.7(4.1) hours and received amean duration of 2.5 (1.1) days of therapy. Eight (50%) patients wereconverted to warfarin with 62.5% achieving a therapeutic INR in amean of 2.4 (0.9) days. Four patients (25%) percent had a significantadverse drug reaction requiring a blood transfusion. CONCLUSION: Upon retrospective review of argatroban dosing, itwas found that a therapeutic aPTT was achieved in 16 hours fortreatment of HIT or HITTS. Further review revealed deficiencies inprocess and outcomes. The argatroban dosing protocol was revisedand the pharmacists received education regarding argatroban dosing.As a result, the time to achieve a therapeutic aPTT decreased andmore patients achieved a therapeutic INR prior to discharge.

277. Tranexamic acid and decreased blood utilization. Tracy S.Elliott, Pharm.D.; Cleveland Clinic-Fairview Hospital, Cleveland, OH PURPOSE: To determine if tranexamic acid use can decrease bloodtransfusion requirements and have an effect on hemoglobin levels. METHODS: One hundred eleven patients underwent either total kneeor total hip replacement surgery. Twenty-eight patients were giventranexamic acid 15 mg/kg prior to surgery. The units of bloodtransfused, percent of patients transfused, and average change inhemoglobin were assessed. RESULTS: 0.1 units of blood per case were used in both the controlgroup and tranexamic acid group for patients who underwent totalknee surgery. Percent of patients transfused in the control group was9% and tranexamic acid group was 6%. Average change inhemoglobin was 4.4 g/dL and 4.2 g/dL for the control and tranexamicacid groups respectively. 0.4 units of blood/case were used in thecontrol group and were used in the tranexamic acid group for patientswho underwent total hip surgery. Percent of patients transfused in thecontrol group was 24% and the tranexamic acid group was 10%.Average change in hemoglobin in the control group was 5.2 g/dL and4.4 g/dL for the tranexamic acid group. CONCLUSIONS: For patients who underwent total knee surgery,tranexamic acid did not appear to affect the overall amount of units ofblood transfused but did appear to have a significant effect on theoverall percent of patients transfused. The increase in hemoglobinbetween the knee surgery test groups was of questionable significance.For patients who underwent total hip surgery, tranexamic acidappeared to have a highly significant effect on the overall amount ofunits of blood transfused decreasing the overall blood use by 75%.Tranexamic acid appeared to have a highly significant effect on theoverall percentage of patients transfused. Tranexamic acid appeared tohave a significant positive effect on the post-operative hemoglobin inthese cases.

278. Impact of hospital-based pharmacist advocates in caretransitions: identification and description of medication relatedinterventions after patient discharge from hospital to home. RimaA. Mohammad, Pharm.D.1, Jenny J. Kim, Pharm.D.2, Amy C. Donihi,Pharm.D.1, Kim Coley, Pharm.D.1; (1)University of Pittsburgh Schoolof Pharmacy, Pittsburgh, PA; (2)University of Pittsburgh MedicalCenter, Pittsburgh, PA PURPOSE: Adverse drug events, medication discrepancies and lackof patient understanding of the treatment plan are problems that oftenoccur after hospital discharge. The primary objective was to describe

medication related interventions conducted by hospital-basedtransition of care pharmacists following hospital discharge. METHODS: Inpatient pharmacists conducted a standardizedtelephone medication evaluation within 72 hours of their patients’discharge to home. Pharmacists resolved identified medication-relatedproblems by counseling the patient and contacting the patient’sphysician, pharmacy, and/or health plan, as needed. All interventionswere documented in the patient’s outpatient electronic medical record.Interventions were classified into four categories: (1) therapeutic drugmonitoring, (2) resolution of medication discrepancies (3) medicationand adherence counseling, and (4) identification and prevention ofadverse drug events (ADEs). RESULTS: Of 58 patients discharged to home, 45 (77.6%) weresuccessfully contacted and evaluated. The mean number of scheduledand “as needed” medications at discharge was 9 (range 2–22) and 2(range 0–7), respectively. Pharmacists made 86 medication-relatedinterventions in 43 patients (1.9 ± 1.2 interventions per patient). Thirty(34.9%) interventions were resolution of medication discrepancies,including 13 medications incorrectly omitted by the patient, 8prescribing errors at discharge, 5 financial-related issues, and 4incorrect doses or medications taken by the patient. In addition, 29interventions (33.7%) were therapeutic drug monitoring, 16 (18.6%)were medication and adherence counseling, and 11 (12.8%) wereADE-related. Medications most commonly intervened on weregastrointestinal agents and antibiotics. On average, pharmacists spent23 (range 5–120) minutes on each patient follow-up. CONCLUSION: Most patients experience at least one medication-related problem after hospital discharge. Hospital-based pharmacistscan positively impact their patients’ care during the transition fromhospital to home by resolving important medication-related problemsand needs.

279. Impact of inappropriate vitamin K use for management ofelevated international normalized ratios on hospital length of stay.Denise M. Kolanczyk, Pharm.D., BCPS, Alexander J. Ansara,Pharm.D., BCPS; Indiana University Health Methodist Hospital,Indianapolis, IN PURPOSE: The CHEST guidelines provide recommendations for themanagement of a supratherapeutic international normalized ratio(INR) regardless of bleeding. Currently there is no literaturedescribing the impact of inappropriate vitamin K use on hospitallength of stay (LOS). The primary objective is to determine if theinappropriate use of vitamin K for the reversal of supratherapeuticINR prolongs LOS. Secondary objectives include the assessment ofadherence to the CHEST guidelines for vitamin K prescribing and toevaluate the time to achieve a therapeutic INR when re-initiatingwarfarin. METHODS: Retrospective chart review of 300 patients with asupratherapeutic INR admitted to Methodist Hospital between July 1,2008 and October 31, 2010. Therapy for reversal of a supratherapeuticINR was defined as discontinuation of warfarin or administration ofvitamin K. RESULTS: Vitamin K was administered to 150 (50%) of 300patients. 81 out of 300 patients were inappropriately managed for asupratherapeutic INR. There was no statistical difference among LOSamong patients who were inappropriately managed (12.45 days versus12.43 days; p=0.46). Adherence to the CHEST guidelines was assessedin 219 patients (73%). The time it took to achieve a therapeutic INRafter warfarin initiation did not differ among treatment groups(p=0.41). However, patients who received vitamin K inappropriatelymay have prolonged LOS. CONCLUSION: Inappropriate management of a supratherapeuticINR did not prolong LOS, but patients who received vitamin Kinappropriately may have a prolonged LOS.

Ambulatory Care

280. Results of a pharmacist-managed Cardiovascular RiskReduction Clinic at a Veterans Affairs Medical Center. ChabelyRufin, Pharm.D., Elizabeth C. Hamilton, Pharm.D., Crystal J. Wink,Pharm.D.; Ralph H. Johnson VA Medical Center, Charleston, SC PURPOSE: Describe the clinical effectiveness of a pharmacist-managed Cardiovascular Risk Reduction Clinic (CRRC) in attaining


blood pressure goals. METHODS: The study population was defined as patients followedin the CRRC for hypertension between June 1, 2007 and September30, 2010 with at least two clinic visits. The percent of patientsattaining goal systolic and diastolic blood pressure values upondischarge from the clinic or end of study period (whichever occurredfirst), based on both the Seventh Report of the Joint NationalCommittee on Prevention, Detection, Evaluation, and Treatment ofHigh Blood Pressure (JNC 7) guidelines and performance measuregoals were determined. The number of clinic visits required to attainJNC 7 blood pressure goals were measured. The cumulative results ofthe CRRC were compared to the annual performance of the facility asa whole, in meeting predetermined blood pressure performance goals. RESULTS: The CRRC assisted in reaching the JNC 7 blood pressuregoal in 89% of patients with HTN and no compelling indication and77% of patients with hypertension and diabetes and/or chronic kidneydisease. JNC 7 blood pressure goals were achieved in a mean of 2.85and 3.47 visits for patients without and with compelling indications,respectively. The CRRC assisted in reaching the blood pressureperformance goal in 89% of patients with HTN and no compellingindication (vs. facility achievement in 71-80% depending on yearreviewed), and in 91% of patients with hypertension and diabetes (vs.facility achievement in 70–84% depending on year reviewed). CONCLUSION: The pharmacist-run CRRC was successful inreaching both JNC 7 and facility performance measure blood pressuregoals in a timely manner, and overall exceeded the annualperformance of the facility. Implementation of a CRRC may assist inreaching performance measure goals and reduce the risk ofcardiovascular events.

281. Impact of a pharmacist-managed diabetes clinic on glycemiccontrol using concentrated U-500 regular insulin. Tzu-Ying(Yasmina) Lee, Pharm.D., BCPS, Anthony Firek, M.D.; VA LomaLinda Healthcare System, Loma Linda, CA PURPOSE: Diabetic patients with severe insulin resistance are agrowing challenge for practitioners. Many of these patients continue tohave inadequate glycemic control despite large dose of insulin. Casereports and retrospective studies have demonstrated that concentratedU-500 regular insulin (U-500) is effective at lowering A1c in thesepatients. We developed a pharmacist-managed diabetes clinic focusingon patients with A1c values of > 9% at Loma Linda VA HealthcareSystem. These patients are at higher risk for complications and are ahigh resource utilization group. Many of these patients were using over200 units of conventional insulin U-100 and are therefore candidates touse U-500. This study evaluated the effectiveness of a U-500intervention program to improve diabetes control. METHODS: This is a retrospective chart review of patients seen inthe pharmacist-managed diabetes clinic who were initiated on U-500.Patients were included if they have been on U-500 for at least 2months with follow-up A1c 2-6 months after initiation of U-500. A1c,body mass index (BMI), and total daily dose of insulin (TDDI) werecollected at initiation and 2-6 months after initiation of U-500. RESULTS: Of the 100 patients followed by pharmacist-manageddiabetes clinic since its establishment, 7 patients met the inclusioncriteria. All patients were male with mean age of 63±9.85 years, meanbaseline A1c of 10.5±1.04%, mean baseline BMI of 36.69±4.76, andmean TDDI of 249.57±17.88 units. The mean reduction in A1c frombaseline following 2–6 months of U-500 therapy was -2.2%±1.0%.The mean increase in BMI was +1.05±1.61 and the mean increase inTDDI was +86.86±122.27 units. CONCLUSION: A pharmacist-managed diabetes clinic demonstratedshort term but clinically significant improvement in glycemic controlin poorly controlled insulin resistant patients using U-500.

282. A pharmacist-run collaborative care program in a free urbanprimary care clinic. Lauren J. Jonkman, Pharm.D., BCPS1, SharonE. Connor, Pharm.D.1, Mary I. Herbert, M.S., M.P.H.2, Sara Mrvos,Pharm.D., Candidate, 20143; (1)University of Pittsburgh School ofPharmacy, Pittsburgh, PA; (2)UPMC Department of General InternalMedicine, Pittsburgh, PA; (3)Duquesne University Mylan School ofPharmacy, Pittsburgh, PA PURPOSE: Pittsburgh’s Birmingham Free Clinic (BFC) serves agrowing population of patients with chronic diseases. BFC’s walk-in

model requires patients to return monthly, which works to provideaccess for new patients, but is less-than-ideal for patients needingcontinuing care. With limited volunteer physician staffing and thus,physician continuity, BFC developed a pharmacist-run appointment-based collaborative care program to provide on-going care andmedication refills to patients with chronic diseases. In this assessmentwe investigate drug-related problems (DRPs), interventions, andclinical outcomes for program participants. METHODS: This retrospective review included all patients with atleast one pharmacist visit since program initiation (June 2009–May2011). We recorded demographics, number of pharmacist visits,clinical data, DRPs, and interventions. The University of PittsburghMedical Center’s quality improvement committee approved thisproject. RESULTS: Sixty-four patients had at least one pharmacist visit in theperiod assessed with a total of 251 visits. The majority of patientswere middle-aged (49.5 years), male (54.9%), black (51.6%), low-income ($640/month), and housed (59.3%). 115 DRPs were identified(average 1.8/patient; 0.46/visit), most common being “dose too low”(34.6%) and “non-compliance “(23.4%). 590 interventions were made(average 9.2/patient; 2.35/visit), most common being “educationprovided” (67.7%) and “referred to lab” (13.7%). Of those withdiabetes (45.3%), baseline A1C was 8.0% (5.6–11.6%), blood pressure134.6/85 mmHg (108–180/64–110 mmHg), and LDL 89.1 mg/dL(45–136 mg/dL). No statistically significant changes were seen forA1C or blood pressure; LDL decreased 10.2 mg/dL (p=0.033).However, 83.3% with A1C > 9% at baseline (6 patients) saw an A1Creduction. CONCLUSION: While we did not find significant clinicalimprovements, most had reasonable disease control at baseline.Improvements are complicated by patient social situations and timelyaccess to laboratory services for disease monitoring. This projecthighlights the potential role for pharmacists in resource-poor settingsto provide chronic care that extends the traditional primary careinfrastructure.

283. Highlighting the work of the Ambulatory Care PRN in 2011.Marissa E. Quinones, Pharm.D.1, Renee Koski, Pharm.D., CACP2,Lea E. dela Pena, Pharm.D., BCPS3, Matthew Pitlick, Pharm.D.,BCPS4, Sarah M. Westberg, Pharm.D., BCPS5; (1)Parkland, Dallas,TX; (2)Ferris State University College of Pharmacy, Marquette, MI;(3)Midwestern University Chicago College of Pharmacy, DownersGrove, IL; (4)St. Louis College of Pharmacy, St. Louis, MO;(5)University of Minnesota College of Pharmacy, Minneapolis, MN PURPOSE: To highlight the Ambulatory Care PRN in 2011. METHODS: The Ambulatory Care PRN is composed of a largegroup of clinical pharmacists practicing in a variety of ambulatorycare settings, including resident and student members. As of April2011, we have a total of 1308 members in the PRN. This year thePRN offered free memberships for PGY2 ambulatory care residentsand so far we have had an increase from 7 in 2009–2010 to 19participants during 2010–2011. RESULTS: There are a total of 8 committees in the ambulatory carePRN. Each committee has been charged with several tasks this year,including working on the FIT scholarship applications form, workingon budget/request for funds process, and working on ways to increaseresident/student membership. The resident/student committee has beenworking on increasing contributions to the ACCP Resident andStudent Travel Awards from 2 to 4, organizing a PRN roundtablediscussion and informal resident/student lunch during the ACCPmeeting. The communication committee continues to monitor theambulatory list serve to ensure members are following proper postingpolices/procedures and has been working on updating the Survivalguide with hopes to publish a new edition in 2013. The PRN isdedicated to supporting and advancing high level research among it’smembers and will continue to seek applications in the future for FITand nurture young faculty and residents with the Seed Grant. Theeducation committee finalized the annual meeting topics regardingnew developments in hypertension and dyslipidemia. CONCLUSION: Overall, the Ambulatory Care PRN has worked veryhard and continues to grow each year, offering its members numerousopportunities for professional development.

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284. Role of a pharmacist in a patient-centered medical home foruniversity employees. Erica F. Pearce, Pharm.D.1, William T.Manard, M.D2, Gillian S. Stephens, M.D.2; (1)St. Louis College ofPharmacy, Saint Louis, MO; (2)Saint Louis University, Saint Louis,MO PURPOSE: The patient-centered medical home (PCMH) has beenincreasingly endorsed both by consumer groups and medicalorganizations as an appropriate model upon which to build a reformedprimary care delivery system in the United States. Despite the role ofmedications in the care of patients with acute and chronic disease, theincorporation of pharmacists’ medication therapy services within thePCMH is still in its infancy. The objective of this project is to discussthe integration of a clinical pharmacist in the Saint Louis UniversityPCMH. METHODS: The Saint Louis University PCMH is a family medicineclinic that combines a multidisciplinary team of health careprofessionals that provides care for Saint Louis University employeesand their families. A part-time clinical pharmacist provides servicesthat incorporate the following five components: 1) medication therapymanagement (MTM); 2) disease state management (DSM); 3) healtheducation; 4) drug information; and 5) interprofessional integrationand coordination of care. RESULTS: The development phase included identifying diseasestates most in need of additional management, establishing a referralprocess, investigating the process for billing and reimbursement forservices, and educating referring providers about the services providedby the clinical pharmacist. The multidisciplinary team of the SaintLouis University PCMH has enthusiastically endorsed theincorporation of clinical pharmacy services. The clinical pharmacist isexpanding access to medication therapy services to two additionalclinic locations. CONCLUSION: Pharmacists can play a fundamental role in PCMHand make significant contributions to patient care across health caresettings. Such innovations in the primary care setting create a uniqueniche for pharmacists to use their skills. The clinical pharmacyservices in the Saint Louis University PCMH will serve as a model toobjectively assess the therapeutic outcomes, safety, and cost-effectiveness of incorporating a pharmacist into the PCMH.

285. Reimbursed medication therapy management services in acommunity health center for a Medicare population. Rebekah E.Sherman, Pharm.D., CDE, Leslie A. Vitin, Pharm.D., CDE;Northeastern University, Boston, MA PURPOSE: To describe medication therapy management (MTM)services provided at a community health center (CHC) for purposes ofdemonstrating a successful model for pharmacy intervention anddirect payer reimbursement. METHODS: A retrospective analysis of pharmacy interventionscompleted during MTM visits over a seven month period from April2010 to October 2011 was performed. The database included only MTMservices reimbursed through Outcomes Pharmaceutical Health Care incoordination with the primary insurer, Senior Whole Health. MTMservices were conducted face to face solely with the pharmacy team. RESULTS: Within the seven month period, 22 patients out of over200 eligible patients were provided MTM services for a total of 34interventions including comprehensive medication reviews, patientconsultations, and prescriber consultations. Ten different types of drugtherapy problems (DTPs) were identified. Interventions to resolveDTPs ranged from patient consultations for medication non-adherence(n=7) to prescriber consultations for changes in therapy (n=15).Ninety three percent of all patient and prescriber consultations wereaccepted without revision. The average time spent on a singleintervention was 38 minutes, and the average reimbursement was$29.47 per intervention. The average number of interventions perpatient was one and a half. MTM fees reimbursed by OutcomesPharmaceutical Health Care amounted to approximately $1002.00 for34 interventions in comparison to the total estimated cost avoidance(ECA) which reached $51,219.25 CONCLUSION: There is a clearly demonstrated need for theprovision of MTM services based on the significant number ofinterventions made in a small sample population. The cost of MTMservices to insurers is justified in the ECA associated with pharmacyinterventions.

286. Pharmacist-managed diabetes service in a rural free clinic.Katherine R. Gerrald, Pharm.D., BCPS, Julie M. Sease, Pharm.D.,BCPS, Meg A. Franklin, Pharm.D., Ph.D.; Presbyterian CollegeSchool of Pharmacy, Clinton, SC PURPOSE: To determine the impact of pharmacist education,monitoring, and management of patients with type 2 diabetes mellitus(DM) enrolled in a free clinic that serves a rural indigent population. METHODS: Data from 81 patients continuously enrolled in a newlyestablished pharmacist service were analyzed over 18 months. Patientswere ≥18 years of age, qualified for free care based on income and/orinsurance status, and had a diagnosis of type 2 DM. Under acollaborative agreement, pharmacists educated patients on DM,counseled patients on lifestyle modifications, assessed appropriatenessof drug therapy, and managed drug therapy for DM and associated co-morbid conditions. Clinical impact was measured by changes frombaseline in hemoglobin A1c (A1c) levels, blood pressure, and lipidlevels. Economic impact was calculated based upon expected savingsper 1% decrease in A1c levels. RESULTS: Mean A1c levels were 10.7% at baseline (SD ±2.4%). At18 months, A1c levels decreased an average of 2.1% (P<0.001), and28.4% of patients had an A1c ≤7%. Significant decreases in meanvalues were also noted for systolic blood pressure (SBP) (P=0.0023),LDL cholesterol (P <0.001), and triglycerides (P=0.003). Compared tobaseline, a significant number of patients achieved A1c goal(P<0.001), SBP goal ≤130 mmHg (P=0.023), LDL ≤100 mg/dL(P<0.0007), and triglycerides ≤150 mg/dL (P<0.0018) by 18 months.A significant number of patients reached a total of 842 interventionswere documented, of which 76.8% involved therapy modification.Over 50% of the modifications were increases to current doses, and30.3% were initiating new therapy. Based on an expected savings of$1,118 per 1% decrease in A1c levels, the average savings per patientwas $2,382, for a total savings potential of $192,167. CONCLUSION: Pharmacist management of patients with type 2 DMhas the potential to significantly impact clinical outcomes and improvecosts of care for patients in underserved rural areas.

287. Collaborative health risk assessment and managementprogram between the university pharmacy clinic and cityemployees. Krista D. Capehart, Pharm.D., M.S.Pharm., MichaelO’Neil, Pharm.D., Michael Bottorff, Pharm.D., FCCP; University ofCharleston School of Pharmacy, Charleston, WV PURPOSE: The purpose of the collaboration is to provide medicationtherapy management services to Charleston, West Virginia cityemployees in conjunction with the City’s Employee Health RiskManagement Program. METHODS: All city employees and dependents were required tocomplete a comprehensive health risk assessment (HRA) in the fall of2010. The collaborative program with the City was created based onthe HRA results. Patients may self-refer to the pharmacy clinic or bereferred by the City’s free physician assistant-run health clinic.Services provided include medication therapy management, chronicdisease management for diabetes, cholesterol, hypertension, heartfailure, asthma, COPD, smoking cessation, pain management, andsubstance abuse prevention. The City will reimburse the PharmUCPatient Care Clinic on a fee-for-service basis. The services are free tothe employee and dependents and can be utilized while at work withouttaking paid or unpaid time off. Adherent participants to the Health RiskManagement Program receive a discount on their health premiums. RESULTS: An agreement was reached with the City of Charlestonfor the PharmUC Patient Care Clinic to be a part of the City’sEmployee Health Risk Management Program. Utilizing theappropriate national Guidelines and/or quality indicators for eachcondition will be examined at six and twelve months. Also, workproductivity indicators and overall healthcare savings will beevaluated. Employee satisfaction with the health plan before and afterProgram implementation will be assessed. CONCLUSIONS: Opportunities exist for pharmacy-based clinics tocontract with insurers, particularly self-insured companies, to facilitateimprovement in the management of health risks. The City ofCharleston is taking a proactive step to improve the health of itsemployees and beneficiaries by recognizing the benefits that clinicalpharmacy can offer and incorporating these services into their healthplan.


288. Development of an automated tool to document clinic-basedpharmacists’ activities. Stephen F. Eckel, Pharm.D., MHA, BCPS,Lindsey B. Poppe, Pharm.D., M.S., BCPS, Sarah K. Ford, Pharm.D.,BCPS, CPP, Caron P. Misita, Pharm.D., BCPS, CPP, Lauren B.McKnight, Pharm.D., CPP, Sujing Yang, B.S., Ian R. Willoughby,Pharm.D.; University of North Carolina Hospitals, Chapel Hill, NC PURPOSE: The University of North Carolina Hospitals (UNC) hasbeen rapidly increasing the number of pharmacists practicing in theclinic setting. Over the past 3 years, UNC has added 8 pharmacistpositions, representing nearly a 200% growth. North Carolina has aunique advanced pharmacy practice model, allowing clinicalpharmacist practitioners to independently evaluate patients andprescribe under protocol. With the diversity of clinics represented andtheir increasing distance from the hospital, an automated tool neededto be developed to document each pharmacist’s activity within theclinic setting. METHODS: A series of meetings occurred with the clinic-basedpharmacists to understand their individual involvement in patient care.Specifically, the goal was to determine activities documented in theelectronic health record (EHR) that are a part of caring for ambulatorypatients. Information technology was consulted to determine if thisdata could be automatically collected from the EHR and compiled intoa routine report. After comparison of manually collected data to thegenerated report and correction of any discrepancies, the report is nowgenerated automatically on a biweekly basis. RESULTS: The following parameters were determined to be markersof clinic-based pharmacists’ activity: medications updated, medicationprofiles reviewed, clinic notes prepared, allergies updated,interdisciplinary communications and patient phone calls addressed,and electronic prescriptions transmitted. These parameters have beendeveloped into a dashboard to summarize each pharmacist’s activity inthe clinic setting. CONCLUSION: This tool has been a means of measuring pharmacistactivity in the clinic setting. As UNC recruits additional pharmacists,their documented interactions with patients will be incorporated intothis tool. Further research is needed to correlate these activitymeasurements with clinic-based pharmacists’ impact on patient care.

289. Implementation of a pharmacist-led medicationreconciliation service in a federally qualified health center.Marissa C. Salvo, Pharm.D.; University of Connecticut - School ofPharmacy, Storrs, CT PURPOSE: Patient appointments following hospital discharge requirethe primary care provider (PCP) to coordinate a variety of services,including but not limited to medication reconciliation, laboratorymonitoring, and referrals. Utilizing a pharmacist to completemedication reconciliation and communicate identified discrepancieswith possible resolution to the PCP prior to the patient’s visit allowsthe provider additional time to focus on patient care. METHODS: Following patient discharge, the PCP receives hospitaldischarge documents through the electronic medical record (EMR)and determines if the patient requires medication reconciliation, basedon polypharmacy or concomitant medical conditions. The PCPelectronically sends the documents to the pharmacist who reviews thedischarge medication list with respect to the patient’s outpatient EMRmedication list. The pharmacist then calls the patient to determineactual medication use. Following reconciliation, the pharmacistupdates the patient’s EMR medication list and notifies the PCP ofmedication discrepancies and potential resolutions through the EMR.In addition, the pharmacist evaluates therapy to recommendmedication therapy modifications, laboratory monitoring, or additionaldisease state management. All recommendations are recorded in theEMR. RESULTS: The pharmacist identified numerous discrepancies amongthe discharge documents, outpatient medication list, and patient-reported medication use. A variety of recommendations were proposedto the PCP, including medication adjustment, laboratory monitoring,and preventative care measures. CONCLUSION: The ambulatory care pharmacist is ideallypositioned to perform medication reconciliation following patientdischarge. In a federally qualified health center with an EMR, thepharmacist has the luxury of access to the discharge medication list,outpatient medication list, patient, and PCP. In addition, the

pharmacist applies clinical knowledge to identify and resolvemedication discrepancies and recommend therapy modification tomaximize medication use and patient outcomes.

290. Incorporating a clinical pharmacist on a medical teamserving the homeless. Marissa C. Salvo, Pharm.D.; University ofConnecticut - School of Pharmacy, Storrs, CT PURPOSE: Clinical pharmacists are active participants on medicalteams in a variety of settings, including acute and outpatient care; theirrole and contributions have been described in numerous pieces ofliterature. However, the clinical pharmacist’s role on a medical teamcomprised of a nurse practitioner (NP), nurse, and care coordinatorserving the homeless is limited. METHODS: A residency trained pharmacist clinician-educatorspends one-half day per week with a medical team associated with afederally qualified health center providing care within a homelessshelter. The pharmacist identifies patients with diabetes orhypertension in order to provide medication therapy management,which includes a medication review, assessment of preventative care,and medication and disease state education. The pharmacistrecommends therapy and laboratory monitoring to the NP as necessaryand documents interventions and recommendations in the electronicmedical record (EMR). In addition, the pharmacist meets with newpatients to complete a medication, medical, social, and family historyprofile. Recommendations for comprehensive care are then made asnecessary. Patients who are current smokers are also encouraged totalk with the pharmacist for smoking cessation counseling. RESULTS: Incorporation of the clinical pharmacist on the medicalteam serving the homeless began in November 2010. All pharmacist-patient encounters and pharmacist recommendations were documentedwithin the patient’s EMR. Members of the medical team weresupportive of the pharmacist’s role and impact on patient care. CONCLUSION: The clinical pharmacy service impacts patient carewithin a homeless population. Pharmacists should consider sharingtheir expertise with a medical team in providing services to apopulation that faces many barriers in the receipt of adequate medicalcare.

291. Development of a medication therapy management service ata free clinic. Catherine A. Bourg, Pharm.D., BCPS 1, Lisa J.Moherman, Pharm.D., CACP2, Tara Whetsel, Pharm.D.3;(1)University of Georgia College of Pharmacy, Athens, GA; (2)WestVirginia University Hospitals, Morgantown, WV; (3)West VirginiaUniversity School of Pharmacy, Morgantown, WV PURPOSE: Medication non-adherence and poor disease outcomesare common among the indigent population. These patients have greatpotential benefits from medication therapy management (MTM)services. However, data describing MTM in the indigent populationare lacking. The purpose of this project was to determine the processby which sustainable MTM services could be implemented at a freeclinic. METHODS: Milan Puskar Health Right, an indigent clinic located inMorgantown, West Virginia, was targeted for development of MTMservices due to its closed circuit model. This ensured that participatingpatients used Health Right exclusively for primary care andprescriptions. The clinic offers primary and specialty care as well aspharmacy services to low-income, uninsured residents of the state.Recruitment for the MTM service was initially based on providerreferral. The electronic medical record was used to identify patientstaking five or more medications, with three or more chronic diseasestates. RESULTS: Patient referrals from primary care providers took placefrom January 2010 to June 2010. Strategies employed to increaseawareness included personalized memos, flyers, and reminder tags inclinic workrooms for providers and flyers in prescription bags forpatients. Each patient completed a survey to evaluate their medicationknowledge and adherence and received a personal medication recordfrom the MTM pharmacist. Barriers to patient recruitment andparticipation in the service included provider availability, projecttimeframe, and appointment cancellations. CONCLUSION: An MTM service utilizing third-year pharmacystudents and faculty preceptors was initiated in September 2010 basedon experience from this project. Despite limitations, a process for

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MTM was implemented and sustainability of pharmacy services wasachieved at Health Right.

Cardiovascular

292E. Evaluation of pharmacist-run anticoagulation managementservice of ventricular assist device (VAD) patients. Paula Horn,Pharm.D., BCPS, CACP, Laura Krumenacker, Pharm.D., Edward T.Horn, Pharm.D., BCPS, Robert J. Moraca, M.D., Walter E. McGregor,M.D., Srinivas Murali, M.D., George G. Sokos, D.O., Raymond L.Benza, M.D., Stephen H. Bailey, M.D.; Allegheny General Hospital,Pittsburgh, PA PURPOSE: To determine the time in therapeutic range, as well as thetype and frequency of adverse events related to anticoagulation inventricular assist device (VAD) patients managed by a pharmacy-runanticoagulation (AC) service. METHODS: A retrospective review was conducted of all VADpatients managed by the AC service from March 1, 2010 to December15, 2010 utilizing medical records, physician order entry system, andclinic documentation. RESULTS: A total of 28 patients were followed by the AC servicewith 552 INR results followed. The percent of INRs in target rangewas 62%. When this was expanded to + 0.2 of the prescribedtherapeutic range, the percentage increased to 78%. Three of the 522INR results were above 5 during the follow-up period (0.54%). Onedose of oral vitamin K was administered. With respect to clinicalevents, 7 patients (25%) experienced 10 bleeding events. Thepredominant event type was gastrointestinal bleed (GIB) (70%). Onepatient had a fatal hemorrhagic stroke. The mean INR at eventdiagnosis was 2.6; median 2.5. One patient had a fatal ischemic stroke,with an INR of 1.1 at event diagnosis. CONCLUSIONS: This data shows that a pharmacist-run AC servicemaintains VAD patients’ anticoagulation therapy within therapeutictargets similar to those reported in the literature. This studydemonstrates that pharmacist-run AC services can achieve tightcontrol of anticoagulation management in a high-risk patientpopulation. Presented at Anticoagulation Forum, Boston, MA, May 5–7, 2011.

293. Opportunities for clinical pharmacist intervention in thepharmacotherapy of patients with left-ventricular assist devices.Douglas L. Jennings, Pharm.D., BCPS, (AQ-CV), Cheryl Smith, RN,Robert Brewer, M.D., Celeste Williams, M.D.; Henry Ford Hospital,Detroit, MI PURPOSE: Left-ventricular assist devices (LVADs) represent a life-saving modality for patients with advanced heart failure. Given thecomplex pharmacotherapy requirements of these patients, the potentialfor medication error is high. The purpose of this project was todetermine the opportunity for participation of the clinical pharmacistin the multidisciplinary care of patients with LVADs. METHODS: A retrospective review was conducted for patientsadmitted to the Cardiothoracic Surgery (CTS) service at our institutionand implanted with the LVAD from July 1st, 2009 to June 30th, 2010.Ambulatory LVAD patients who were readmitted to the AdvancedHeart Failure (AHF) service during the same time period were alsoincluded. Data collection included demographics, past medical history,and prescribed medications. The primary endpoint was the number ofdocumented interventions by the clinical pharmacist during the studyperiod. Pharmacist interventions were categorized according to classof medication (i.e., antibiotic, anticoagulant, etc.) and type ofintervention (dose correction, discontinue uneeded therapy, etc). RESULTS: A total of 30 patients had a LVAD implanted and wereadmitted to the CTS service, while 32 ambulatory LVAD patients werereadmitted to the AHF service (71% male, 58% Caucasian, 98%HeartMate II®). The clinical pharmacist was responsible for 400interventions in LVAD patients during the study period. Newly-implanted LVADs admitted to the CTS service had 262 interventions(average of 8.7 interventions per patient), while those readmitted tothe AHF service received 138 interventions (average of 1.8interventions per patient). Overall the most common type ofpharmacist intervention was change in dose/route/frequency (33%),while the most common reason for pharmacist intervention wastreatment of a disease not controlled on present therapy (36%). Most

of the interventions were with antimicrobial (43%) or cardiovascular(26%) agents. CONCLUSION: Clinical pharmacists have significant opportunityfor participation in the multidisciplinary care of patients with LVADs.

294. Frequency of aminophylline use for reversal of dipyridamoleand regadenoson. Lisa M. Perry, Pharm.D., Mei Tse, Pharm.D.;Portland Veterans Affairs Medical Center, Portland, OR PURPOSE: Dipyridamole and adenosine are the commonpharmacologic stress agents used to mimic the effects of exercise oncoronary blood flow. Regadenoson is the newest pharmacologic stressagent indicated for stress MPI and is selective for the A2A receptor. Itis thought that there are more undesired symptoms and safetyconcerns that occur when multiple adenosine receptors are stimulated.The Portland VA Medical Center’s drug of choice for reversal of thesepharmacologic agents is aminophylline. The objective of thisretrospective chart review was to compare the incidence of adversedrug events associated with both dipyridamole and regadenoson and toreport the frequency of use of aminophylline for reversal of these drugeffects.METHODS: The health system’s electronic medical record systemwas used to identify 140 veterans that had received dipyridamole orregadenoson for stress MPI. A retrospective chart review wasperformed. Data was collected on patient demographics, concomitantmedications, vitals, adverse drug events, and receipt of regadenoson ordipyridamole, and receipt of aminophylline. RESULTS: The dipyridamole group reported a total of 52 adverseevents compared to 62 adverse events reported by the regadenosongroup (P=0.05). Mild dyspnea had the largest difference in reportingbetween the two groups with 36 patients in the regadenoson group and4 patients in the dipyridamole group (P=0.003). A total of 63 patientsin the regadenoson group and 61 patients in the dipyridamole grouprequired reversal with aminophylline (P=0.791). CONCLUSIONS: There was a significant trend towards loweradverse effects with dipyridamole than with regadenoson and theadverse effect with the largest difference in reporting between the twogroups was mild dyspnea. There was no significant difference in thefrequency of aminophylline use between the two groups.

295. The implications of clopidogrel black box warning onutilization of platelet aggregation testing in the communityhospital setting. Kathryn M. Momary, Pharm.D.1, Kevin Sponsel,Pharm.D., Candidate1, Kelly Blanchfield, Pharm.D.2; (1)MercerUniversity College of Pharmacy and Health Sciences, Atlanta, GA;(2)Saint Joseph’s Hospital of Atlanta, Sandy Springs, GA PURPOSE: Patients producing less clopidogrel active metabolite, dueto possession of CYP2C19 loss-of-function alleles, have decreasedinhibition of platelet aggregation and are at increased risk forcardiovascular events. The FDA issued a black box warning forclopidogrel in March 2010 suggesting that clopidogrel not be used inpatients with CYP2C19 loss-of-function alleles. However, at mostinstitutions CYP2C19 genotyping is a “send-out” laboratory whileplatelet aggregation testing with VerifyNow can be done “in-house”.VerifyNow testing has also been associated with risk of cardiovascularevents with clopidogrel therapy. The objective of this study was toassess changes in utilization of the VerifyNow test before and after theclopidogrel black box warning was released, in March 2010, at acommunity hospital. METHODS: We conducted a retrospective medical record review ofall patients undergoing VerifyNow testing at a community hospital pre(Nov. 2009 to February 2010) and post (April 2010 to July 2010) therelease of the clopidogrel black box warning. Documented indicationsfor VerifyNow testing were categorized as related to safety(bleedingrisk) or efficacy(thrombosis risk). Data were compared between thepre and post black box warning groups using Chi-squared tests. RESULTS: Data from 151 patients undergoing VerifyNow testingwere collected, 73 from before the black box warning and 78 after.The majority of tests were performed by surgery services (pre 88% vs.post 66% p=0.002) to assess bleeding risk with clopidogrel. There wasa non-significant increase in VerifyNow testing to assess the efficacyof clopidogrel after the black box warning release (1.4% vs 6.5%p=0.121). CONCLUSION: Use of VerifyNow testing to assess the efficacy of


clopidogrel did increase slightly after release of the black boxwarning, however this was still uncommon. The majority ofVerifyNow testing at a community hospital is related to bleeding riskwith surgical procedures.


296. Clinical pharmacy technicians: impact in cardiology andcritical care pharmacy services. Kena Lanham, Pharm.D., LaDonnaS. Cangany, CPhT; Saint Vincent Hospital, Indianapolis, IN PURPOSE: Pharmacy departments continue to struggle with balancebetween providing quality services while streamlining costs. Thus,pharmacy technicians have taken on roles previously done bypharmacists. Growing responsibilities to both staff and clinicalpharmacists led to the development of two positions for clinicalpharmacy technicians. The technicians provide both clinical andadministrative support in the areas of cardiology and critical care. METHODS: Clinical support-The cardiology clinical techniciangathers laboratory data for the pharmacist to use in dailymultidisplinary heart failure rounds. The critical care techniciangathers both laboratory data and medication use data. Laboratory datais used to assess for dosing changes for renal impairment, parenteralnutrition, and monitorable medications. The medication use datatracks the use of continuous sedative infusions for the pharmacists touse in assessing daily sedative interruptions. Administrative support-Both technicians are involved in data collection for various projectsincluding drug utilization evaluations, core measures adherenceimprovement, and medication management policy implementation. RESULTS: Specific clinical technician responsibilities have changedwith each challenge presented to the pharmacy department. Toimprove adherence to heart failure core measures, the cardiologyclinical technician became involved in a medication reconciliationpilot to improve the discharge instructions measure. The critical caretechnician’s work enables pharmacists to intervene on sedation andanalgesia misadventures by targeting sedative infusions and ensuring adaily sedative interruption takes place. With each drug shortage, theclinical technicians have the ability to survey specific drug usage sothat the clinical specialists have hard data to use to developcontingency plans. CONCLUSION: The clinical technician position is viewed as anasset to cardiology and critical pharmacy teams. Their work allowspharmacists to practice patient focused pharmaceutical care and setpriorities and goals to improve patient care.

297. Implementation of telepharmacy services in a multihospitalhealth-system. Matthew Jenkins, Pharm.D., M.S., Madalyn Bates,R.Ph., Meredith Jernigan, Pharm.D., Deborah Redmond, M.B.A.,MHA; University of Pittsburgh Medical Center, Pittsburgh, PA PURPOSE: The implementation of a telepharmacy service to provideround-the-clock medication order review by pharmacists is described. METHODS: Three critical access hospitals (CAHs) workedcollaboratively as part of a network of hospitals implementing thesame electronic health record (EHR), computerized prescriber-order-entry (CPOE) system, and pharmacy information system to serve asthe health information technology (HIT) backbone supporting round-the-clock medication order review by pharmacists. Collaborationpermitted standardization of workflow policies and procedures.Through the HIT backbone, both onsite and remote pharmacists weregiven access to the medication orders, the pharmacy informationsystem, and other patient-specific clinical data in patients’ EHRs.Orders are typically reviewed within 60 minutes of when they areentered into the system. As part of the pilot, telepharmacy serviceswere provided by three pharmacists employed by the health system.Using a virtual network or terminal server, pharmacists directlyaccessed hospital servers and information systems to conduct theirwork. Telephone calls were automatically routed to the telepharmacistso that handling of nursing and other calls would be transparent tostaff. Hours of telepharmacy service were 6 p.m. to 7 a.m. Mondaythrough Sunday evenings. RESULTS: Order-processing time for routine orders averaged 15minutes, while stat order processing averaged 9 minutes. For routineorders, turnaround times greater than 60 minutes became almostnonexistent after telepharmacy services were implemented. The total

number of clinical interventions documented increased by 20%. CONCLUSION: The implementation of a telepharmacy model in amultihospital health system increased access to pharmacy services,expanded hours of service, improved the processing of physicianmedication orders, and increased clinical pharmacy services and costavoidance.

298. Warfarin monitoring by pharmacists versus usual standardof care in a long-term acute care hospital. Helen Feinstein,Pharm.D., BCPS; Kindred Hospital, Pittsburgh, PA PURPOSE: To determine the impact of daily INR monitoring by staffpharmacists in a 72-bed long-term acute care (LTAC) hospital on thenumber of days with supratherapeutic INR levels and bleeding events. METHODS: Comparison of 2 historical cohorts, one consisting ofpatients who received warfarin prior to implementation ofanticoagulation monitoring program, and another consisting ofpatients with continuous warfarin monitoring matched for treatmentindication was undertaken. Patients with diagnoses of deep venousthromboembolism (DVT), pulmonary embolism (PE), and atrialfibrillation hospitalized from April 2010 through March 2011 wereselected from the pharmacy monitoring logs and the percentage ofdays above INR of 3.05 along with the incidence of bleeding wasrecorded. The same clinical indicators were pulled on randomlyselected patients that met the criteria for diagnoses from the hospital’selectronic medical records for the time period starting from April 2009through March 2010. RESULTS: After excluding patients, who had less than 5 consecutiveINRs or artificial heart valves, 37 patients were selected for the controlgroup and 33 patients were chosen from the pharmacist-monitoredgroup. Prior to program implementation, patients spent on average16.3% of days with the supratherapeutic INR, compared to 15.4%after pharmacists started monitoring the patients. Student’s t-test didnot show this difference to be statistically significant (p=0.40145).Four patients had bleeding episodes in the control group compared to3 patients in the monitored group. CONCLUSION: No improvement in patient outcomes withpharmacist warfarin monitoring was observed. However, it is alsoknown that patients in the LTAC setting are more debilitated, presentwith multiple co-morbidities and require concurrent therapy withinteracting drugs that may cause INR fluctuations or bleeding. It ispossible that physicians may not be accepting some recommendationson dose adjustment as well. Staff pharmacists may need more trainingin managing anticoagulation therapy in our institution.


299. Community pharmacist clinical documentation interventionproject. Jamie L. McConaha, Pharm.D., Robert L. Maher, Pharm.D.;Duquesne University Mylan School of Pharmacy, Pittsburgh, PA PURPOSE: To determine if a clinical intervention form implementedinto community pharmacy workflow affected pharmacists’ beliefsabout clinical interventions performed, their perception on jobsatisfaction, and to measure ease of use of such a form in dailypractice. METHODS: Two community pharmacies and pharmacistsparticipated in this pilot program. The clinical intervention form was asimple 7 x 4˝ tear-off pad, developed by the researchers following theprofessional pharmacy services codes (PPS) designed by the NationalCouncil of Prescription Drug Programs (NCPDP). Form incorporationinto daily workflow was studied for 3 months. Pre- and post-surveyswere utilized to determine the pharmacists’ attitudes and perceptionssurrounding their involvement in clinical interventions in communitypharmacy, job satisfaction, and the ease of using the form. RESULTS: Results were analyzed using descriptive statistics. A totalof 557 interventions were documented, the majority being patient-related issues and 31% of those due to drug-related issues. Dosage andduration issues accounted for 16% of all interventions documented. Achange of mode score from a (4) agree to (5) strongly agree wasshown on the post survey of pharmacist attitudes and indicated thatpharmacists valued documentation. The satisfaction survey showed amode score of (4) agree that the documentation form was helpful inidentifying clinical interventions. CONCLUSION: This pilot study on documentation of clinical

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interventions in community pharmacy showed that pharmacists shouldbe able to assess and quantify the clinical activities they perform andvalidated community pharmacists’ beliefs that they perform clinicalinterventions. Implications may include development of an electronicmeans of documenting clinical interventions.

300. Implementation of a herpes zoster immunization service at anindependent community pharmacy. Karen M. Horbowicz,Pharm.D.; Inman Pharmacy, Inc., Cambridge, MA PURPOSE: New legislation that permits pharmacists to immunizepatients against herpes zoster under the scope of a collaborative drugtherapy management (CDTM) agreement was recently passed in theCommonwealth of Massachusetts. However, several barriers still existthat prevent patients from being appropriately immunized, includingvaccine shortages, storage requirements, and third party billing toMedicare Part D. To our knowledge, there are no other communitypharmacies in Massachusetts that offer herpes zoster immunizationsadministered by a pharmacist. METHODS: To implement this novel service in Massachusetts, aCDTM agreement was developed to authorize three full-time,immunization-certified pharmacists to administer herpes zostervaccinations. To participate, physicians must sign the CDTMagreement, write a prescription for the vaccine, and complete ourreferral form. Direct advertising was provided to both patients andlocal physician groups indicating that patients could come on a “walk-in” basis or schedule an appointment for the vaccination. RESULTS: One hundred forty-eight patients were vaccinated sincethe implementation of this pharmacist-managed herpes zosterimmunization program in January 2011. Another 142 patientscompleted the requisite paperwork but have not yet come into thepharmacy for the vaccination. Thirty-four CDTM agreements wereestablished with different primary care providers. Referrals havesteadily increased since implementation. The average reimbursementfrom ten different payers was $168.38. To date, this service hasyielded $4,118.59 in profits and continues to grow. CONCLUSIONS: Our efforts demonstrate that a herpes zosterimmunization service can be successfully implemented within thecurrent regulatory framework, improve vaccination rates, enhancepublic health, and remain profitable. Furthermore, the overwhelmingsupport from participating physicians suggests there may be additionalopportunities for collaboration between community pharmacists andphysicians in the future.

301E. Identifying medication-related needs of HIV patients:foundation for communitypharmacist-based services. Yardlee S.Kauffman, Pharm.D.1, Melissa McGivney, Pharm.D., FCCP1, ElanaBarkowitz, M.P.H.2, Nicole Cerussi, Pharm.D., M.P.H.3, Jan L Pringle,Ph.D.1; (1)University of Pittsburgh School of Pharmacy, Pittsburgh,PA; (2)University of Pittsburgh Graduate School of Public Health,Pittsburgh, PA; (3)UPMC Falk Pharmacy, Pittsburgh, PA PURPOSE: The role of a community pharmacist managing HIVpatients has not been well studied nor have these patients’ perspectivesabout community pharmacist-based services. The purpose of thisqualitative study was to identify medication-related needs of HIV-infected individuals who receive prescriptions from a communitypharmacy and assess their perspectives of community pharmacist-based services. METHODS: Individual, semi-structured interviews were conductedover a three-month period with participants living in both urban andrural areas. Participants were recruited from the Pittsburgh AIDSCenter for Treatment in Pittsburgh, PA and the Ryan White Clinic inJohnstown, PA. Inclusion criteria included: HIV+ males and femalesat least 18 years old who currently take medications and use acommunity pharmacy for prescription fills. Interview questions werebased on: (1) medication-related needs, (2) perceptions of the role ofthe pharmacist in their care, (3) perceived value of pharmacistservices, and (4) preference for implementation of pharmacist-basedservices. All interviews were conducted by the principal investigatorand continued until model saturation occurred. RESULTS: Twenty-nine interviews were conducted: 15 participantsfrom the PACT clinic and 14 from the Ryan White Clinic. Emergingthemes, upon initial review, include: participants who have been on amedication regimen for several years state to be “self sufficient” and

do not feel this service would be beneficial to them. Yet, they do feelthat it may be valuable for patients who are starting new medicationsor changing medications. For those patients interested in the service,they have emphasized patient confidentiality as a key component ofthe service to increase their comfort with a pharmacist. CONCLUSION: Results will better inform pharmacists in urban andrural settings about the needs of HIV/AIDS patients in theircommunity and may guide the implementation or enhancement ofcommunity pharmacist-based services for HIV/AIDS patients. Presented at Present at the American Pharmacists Association AnnualMeeting, Seattle, WA March 25–28, 2011.

302. The role of a community pharmacy resident in expandingclinical pharmacy services within a traditional dispensing model.Jamie Montgomery, RPh, BCPP, Ted J. Turner, Pharm.D., MelanieQuinn, Pharm.D., Jessica Harms, Pharm.D., Sheila Samol, Pharm.D.,Tanya Fabian, Pharm.D., Ph.D., BCPP; Western Psychiatric Instituteand Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA PURPOSE: Patients with serious mental illness are at a higher riskfor developing chronic medical disorders including metabolicsyndrome and have significantly higher rates of premature mortality.Adherence to medications presents a special challenge for thisvulnerable patient population. Community pharmacists can directlyimpact patient care and improve clinical outcomes through innovativedispensing models and specialized pharmacy services. We evaluatedthe role of a community pharmacy resident in expanding clinicalpharmacy services within a traditional dispensing model. METHODS: A total of 50 psychiatric outpatients were identified ashaving complex medication regimens and poor medication adherenceand were enrolled in a pillbox program. Medical and psychiatricmedications were dispensed in a weekly pillbox to promote adherence.Electronic medical records were reviewed to identify individuals withmedical comorbidities including diabetes, hypertension orhyperlipidemia. A comprehensive medication review was conductedand medication education provided to the patient over three visits.Documentation of each visit was sent to the patient’s primary careprovider. RESULTS: Of the 50 patients enrolled in the pillbox program, 27(54%) had co-morbid medical diagnoses of diabetes, hypertensionand/or hyperlipidemia. To date, one-third (9/27) have completed themedication management program. Patients were prescribed an averageof 11 medications with complex dosing regimens. Eighteen drugtherapy problems were identified of which 16 (89%) were resolvedthrough pharmacy interventions with providers. CONCLUSION: The addition of a community pharmacy residentwas important to the success of this pilot project to assess feasibilityof adding clinical pharmacy services to our current workflow.Although patients were enrolled in a structured dispensing program,drug therapy problems including adherence were identified.Pharmacists addressed patient specific medication issues andcollaborated with providers to resolve. Incorporation of clinicalpharmacy services into a traditional dispensing model can improvemedication adherence, address access to care and promote healthoutcomes.

303E. Assessing community pharmacist impact on over-the-counter medication selection. Jamie L. McConaha, Pharm.D.1,Jennifer E. Heasley, Pharm.D.1, Thomas J. Mattei, Pharm.D.2;(1)Duquesne University Mylan School of Pharmacy, Pittsburgh, PA;(2)Mylan School of Pharmacy, Duquesne University, Pittsburgh, PA PURPOSE: To evaluate the financial and clinical outcomes of anover-the-counter (OTC) medication consultation performed bypharmacists and student pharmacists in community pharmacy. METHODS: Pharmacists in community pharmacy settings are soughtafter to provide recommendations on over-the-counter treatments. Thisoccurs by several methods: (a) the patient approaches the pharmacycounter to ask about an OTC product, (b) the pharmacist isapproached while out in the aisle by a patient about an OTC product,or (c) the pharmacist approaches a patient in the aisle if it appears thatthey need assistance. This prospective study looks to quantify thenumber of times these types of interactions occur in preselectedcommunity pharmacies. The impact will be evaluated in five ways: (1)evaluate the effects of pharmacist counseling on OTC medication


purchasing decisions/costs, (2) identify factors that influencepurchasing decisions, (3) assess whether patients or pharmacistsinitiate the consultation, (4) measure prevented OTC medication-related adverse outcomes, and (5) assess patient likelihood to seekOTC counseling in the future. Three tool sets will be utilized to collectdata in the study. The collects information such as the patientsymptoms and healthcare need, initial and final purchase selections,and whether or not the recommendation was accepted. The collectsthe reasoning for recommendations. Lastly, the collects demographicinformation for study participants. RESULTS: A total of 200 surveys have been collected to date. Initialresults show that pharmacists initiate consultation >60% of the time,with 34% of these consultations accepted. The majority of patients(88.72%) have accepted the pharmacist’s OTC recommendation,mainly dealing with cough and cold products (62). Pharmacistrecommendations have resulted in an average savings of $2.95. CONCLUSION: Pharmacist consultation has the potential topositively impact both financial and clinical outcomes associated withthe use of OTC medications. Presented at Presented at the American Pharmacists Associationannual meeting, Seattle, WA, March 26, 2011.

Critical Care

304. Pseudoephedrine for neurogenic shock after acute spinal cordinjury. Jessica L. Johnson, Pharm.D.1, G. Christopher Wood,Pharm.D.2, Jennifer N. Mitchell, Pharm.D.3, Louis J. Magnotti, MD4,Martin A. Croce, MD5, Bradley Boucher, Pharm.D.2, Joseph M.Swanson, Pharm.D.2, Timothy C. Fabian, MD5; (1)FrederickMemorial Hospital, Frederick, MD; (2)University of Tennessee HealthScience Center, Memphis, TN; (3)Veterans Affairs Medical Center,Charleston, SC; (4)University of Tennessee Health Sciences Center,Memphis, TN; (5)University of Tennessee College of Pharmacy,Memphis, TN PURPOSE: Neurogenic shock is common after acute spinal cordinjury (SCI) and may require extended catecholamine therapy.Oral/enteral pseudoephedrine (PSE) may be more convenient than IVvasopressors (VP); however, there are very few reports describingsuch use. This retrospective case series describes the effect of PSE foradjunctive treatment of neurogenic shock in acute SCI. METHODS: Patients admitted to the trauma ICU between2002–2010 with an acute SCI who received scheduled PSE forbradycardia (HR ≤ 50) and/or hypotension (MAP <65) were identifiedusing the hospital database. Patients were classified as a treatmentsuccess if one of the following occurred within 7 days after PSEinitiation: discontinuation of IV vasopressors (VP), or a positiveclinical response (reduction in episodes of bradycardia and/orhypotension). The remaining patients were classified as treatmentfailure or inconclusive. RESULTS: Twenty-one patients were identified. Descriptivestatistics were: male sex 81%, age 40±18 yrs, high cervical SCI 71%,APACHE II score 13±5, injury severity score 39±15, ICU length ofstay 42±24 days, and hospital length of stay 42±24 days. PSE wassuccessful in 10 patients, failed in 4, and had an inconclusive effect in7. In the success group, 5 patients had VP discontinued, 4 had aclinical response, and 1 had both. Patients were classified asinconclusive because of a short duration of PSE use (n=3), receipt ofPSE prior to onset of neurogenic shock (n=3), or labile VPrequirements that made classification difficult (n=1). Groups were notcompared statistically because of low numbers, but there were noobvious clinical differences between groups. CONCLUSIONS: Adjunctive use of PSE for patients withneurogenic shock appears to be beneficial for some patients. As thedrug is relatively inexpensive and easily administered, a trial of PSEseems reasonable in patients who are difficult to wean from IVcatecholamines.

305. Using non-bronchoscopic bronchoalveolar lavage-obtainedrespiratory cultures to guide antimicrobial therapy in patientswith suspected pneumonia. Kay Lyn Lauer, Pharm.D.1, John S.Rinck, RRT1, John P. Kepros, M.D.2, Curtis L. Smith, Pharm.D.3;(1)Sparrow Health System, Lansing, MI; (2)Michigan StateUniversity, East Lansing, MI; (3)Ferris State University College of

Pharmacy, Lansing, MI PURPOSE: The purpose of this study was to determine the influenceof non-bronchoscopic, small volume bronchoalveolar lavage (mini-BAL)-obtained respiratory cultures on the selection or de-escalation ofantimicrobial therapy in mechanically ventilated patients withsuspected pneumonia. METHODS: A retrospective chart review was conducted for patientswho were mechanically ventilated and underwent a mini-BALprocedure between November 10, 2009 and December 10, 2010 toobtain a respiratory sample. Charts were reviewed for date ofprocedure, antibiotics received before the procedure, culture results,and antibiotic changes made subsequent to culture results. Changes inantibiotic therapy were assessed and a cost analysis was performed.The culture results were compared with those of samples obtained viabronchoscopic bronchoalveolar lavage (BAL). RESULTS: Seventy-two patients accounted for 112 mini-BALprocedures. Fifteen of the 112 procedures were excluded. Theincidence of normal flora, no growth, isolation of a specific organismor isolation of a predominant organism in combination with normalflora was 49.5%, 25.8%, 16.5% and 8.2%, respectively, for the mini-BAL samples and 63.3%, 16.7%, 3.3% and 16.7%, respectively, forthe BAL samples. Of the 97 procedures, antimicrobial therapy wasstopped in 26.8% of patients, changed based on susceptibility data in12.4% of patients, expanded in 3.1% of patients and unchanged in57.7% of patients. The cost savings of performing 97 mini-BALprocedures was a total of $10,980 (about $113 per patient) when themoney saved from stopping or changing antibiotic therapy was takeninto consideration. CONCLUSIONS: The mini-BAL procedure is a cost-effective meansof obtaining respiratory samples in mechanically ventilated patientswith suspected pneumonia and is not inferior to BAL procedures forobtaining respiratory samples.

306. Optimizing heparin dosing in patients with cardiac arrestundergoing therapeutic hypothermia. Jessica C. Carney, Pharm,D1, Randall Absher, Pharm D1, Tatiana Daniels, Pharm, D2; (1)TheMoses H. Cone Memorial Hospital, Greensboro, NC; (2)University ofNorth Carolina, Eshelman School of Pharmacy, Chapel Hill, NC PURPOSE: To evaluate and optimize heparin dosing in patientsundergoing therapeutic hypothermia following cardiac arrest. METHODS: A retrospective chart review was conducted betweenOctober 2010 and March 2011, on 34 patients admitted to The MosesH. Cone Memorial Hospital who survived cardiac arrest, underwenttherapeutic hypothermia, and were treated with IV heparin forsuspicion of myocardial infarction. Patients’ baseline characteristics,heparin dosing, and anti-Xa heparin levels during hypothermia wereevaluated. Data from hypothermic patients was compared to ahistorical database of normothermic patients treated with IV heparinfor similar indications. RESULTS: Hypothermic patients required lower heparin boluses anddrip rates to reach therapeutic anti-Xa levels than normothermicpatients. A multiple logistic regression model suggests that optimalheparin dosing for hypothermic patients consists of a bolus of 21units/kg and an initial heparin drip rate of 9.2 units/kg/hr. Minorbleeding was reported in 5 of 34 patients. CONCLUSIONS: As the popularity of therapeutic hypothermia inthe post-arrest patient continues to grow, the use of anticoagulation inthis population is also increasing. It appears a reduced heparin dosingstrategy in hypothermic patients may be adequate to acheive anti-Xalevels in the therapeutic range.

307E. Survey of heparin-induced thrombocytopenia (HIT)laboratory testing and evaluation of a tailored HIT screeningprotocol based on the 4Ts scoring system. Wesly A. Pierce,Pharm.D., Joseph Mazur, Pharm.D., BCPS, BCNSP, Charles S.Greenberg, MD, John Lazarchick, MD; Medical University of SouthCarolina, Charleston, SC PURPOSE: Over-diagnosis of heparin-induced thrombocytopenia(HIT) results in costly and unnecessary laboratory screening andtreatment with direct thrombin inhibitors. Our aim was to evaluate theutility of a modified “4-T’s” scoring system in predicting HIT in ICUpatients and to characterize our treatment of these cases. METHODS: This retrospective review collected data from January

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2009 through June 2010 to include patients who had a platelet factor 4(PF4) assay and/or serotonin-release assay (SRA) drawn while in anICU. Data collected consisted of patient demographics, PF4assay/SRA results, platelet counts, heparin exposure and duration,clinical course, incidence of thrombosis, prescribed medications, andclinical outcome. RESULTS: Of the 82 patients reviewed, only 12 (11.4%) were PF4-positive and of those, 1 (2.3%) was SRA-positive for HIT. Heparinwas discontinued in only 63.4% of these patients. There were nosignificant differences in mean day of platelet fall, mean platelet nadir,and mean percent fall in platelet count between PF4-positive andnegative patients (all p>0.2). There was a significant difference in theproportion of patients with an intermediate to high 4Ts score (66% vs.30%, respectively; p=0.02). The negative predictive value of the 4Tsscore relative to the PF4 and SRA was 92% and 100%, respectively.The estimated cost avoidance potential of the scoring system in thiscohort was $21,450. CONCLUSION: Our modified 4T’s scoring system appears to be aneffective tool for predicting HIT in the ICU and could avoidsignificant drug and laboratory expenditures if implementedprospectively. The clinical management of patients suspected of HITis highly variable at our institution. Clinical protocols and educationencouraging the proper identification and treatment of suspected HITneed to be established. Presented at The Southeastern Residency Conference (SERC) of theOffice of Postgraduate Continuing Education and Outreach -University of Georgia College of Pharmacy Athens, GA, April 28–29,2011.

Drug Information

308. Carbapenems selection by means of the SOJA method. AnaLeandro, Pharm, D, Armando Alcobia, Pharm.D.; Hospital Garcia deOrta, Almada, Portugal PURPOSE: The System of Objectified Judgement Analysis (SOJA)method is a model for drug decision making, for formulary purpose. Inthis method are defined selection criteria for a given group of drugs,each one with a relative weight depending on its importance. Theextent in which each drug fulfils the requirements for every criterion isscored in terms of percentage of the criterion’s weight. In 1998, astudy (Janknegt R. et al. EHP 1998;4(1):5-12) was publishedcomparing Imipenem/cilastatin and meropenem by means of theSOJA method. Since then, two more drugs have become available inEurope: ertapenem and doripenem. In our study, the selection criteriafrom the 1998’s study were applied to the four drugs, with the purposeto evaluate the carbapenem group for a Pharmacy and TherapeuticsCommittee informed decision. METHODS: The SOJA method was applied to the four availablecarbapenems: imipenem/cilastatin, meropenem, ertapenem anddoripenem. The evaluation criteria were selected, and all informationused in drug scoring was collected by literature research. Theexceptions were resistance data and acquisition costs, where specificinformation from our hospital was used. RESULTS: The following selection criteria and relative weight wereused: number of formulations (20); number of approved indications(30); pharmacokinetics (60); antimicrobial spectra (110); efficacy(175); development of resistance (120); general side effects (100);severe side effects (100); drug interactions (75); dosage frequency(45); acquisition cost (105) and experience/documentation (60) Theorder obtained was: meropenem (722), doripenem (646), ertapenem(641) and imipenem/cilastatin (627). CONCLUSION: Meropenem showed a total higher score, showingadded therapeutic value within the carbapenem group. These resultsallow the Pharmacy and Therapeutics Committee to decide based onmore consistent information.

309. Standard operating procedure to develop evidence-basedinformation to support pharmacy and therapeutics committeedecision for formulary management at a university hospital. AnaC. Ribeiro Rama, Ph.D.; Pharmacy Department, Coimbra UniversityHospitals and Center for Pharmaceutical Studies, Faculty Pharmacy,Coimbra University, Coimbra, Portugal PURPOSE: Pharmacy and Therapeutics Committees (PTC) are

responsible for the effective management of medicine’s use throughmaintenance of Hospital Formulary. Standard operating procedures(SOP) were designed to overcome the need to develop strategies forPTC decision support, in response to technology progress along withrising costs, to make available evidence based information. METHODS: Literature search to find guidelines on items ofinformation needed to support PTC’s decisions to develop a model forits delivery. Search to identify resources with valid and evidence basedinformation on each needed item on new medicines and technologies,to develop the systematic strategy to look for information. SOP wastested with 25 medicines and 5 medical devices (MD). RESULTS: Main items needed to support PTC’s decision includecomparative analysis, regarding pharmacodynamic/pharmacokineticprofile, efficacy, safety and economic impact. Search strategies weredeveloped, with keywords and mesh terms, to identify primary andsecondary literature on Medline/PubMed and most essential journals.Information resources identified were characterized regarding qualitycriteria and content. The 80 resources gathered, delivering evidencebased information and quality assessment on new technologies,comprehend websites, freely available, of medicines agencies,governmental and nongovernmental organizations, databases, mainlyfrom UK and USA. Document types include monographs, healthtechnology assessment reports, PCT’s reports and therapy/safetybulletins. Seven paid databases were tested. Response from allresources, vary according to: the item; web resource country of origin;document type; technology and accessibility type. With thisprocedure, PTC has evaluated 5 medicines in 2009, 13 medicines and1 MD in 2010 and 8 medicines and 4 MD in 2011 and has supportedtheir decision to include 12 of 25 medicines and 2 of 5 MD. From2011, 6 medicines and 1 MD wait decision. CONCLUSION: We have created a SOP to find information neededto support PTC decision and develop a model to deliver it.

Education/Training

310E. Assessing the effect of multiple advanced cardiac lifesupport simulations on pharmacy student performance. Jason S.Haney, Pharm.D., BCPS1, Sarah P. Shrader, Pharm.D., BCPS2;(1)South Carolina College of Pharmacy, Charleston, SC; (2)SouthCarolina College of Pharmacy/MUSC Medical Center, Charleston, SC PURPOSE: To assess the effect of multiple advanced cardiac lifesupport (ACLS) simulations on third-year pharmacy studentperformance with 1) managing adult patients with bradyarrhythmias,tachyarrhythmias, and cardiac arrest; 2) preparing medications withsterile technique for use during ACLS; and 3) calculating patient-specific vasopressor administration rates. METHODS: The study was approved by the institutional reviewboard of the Medical University of South Carolina. An ACLSsimulation using a human patient simulator was developed for third-year pharmacy students at the South Carolina College of Pharmacy.Three days prior to the simulation, students received 2 hours of lecturereviewing the pharmacist’s role and pharmacologic agents used inACLS. Students were divided into 26 groups of 3–4 students andassigned a 45-minute session. The students identified and treated threescenarios: sinus bradycardia, ventricular fibrillation, and hypotension.Students rotated roles as team leader/administering respirations,preparing/administering medications, and performingcompressions/operating the defibrillator following each scenario. Aninstructor supervised each session, graded clinical performance, andprovided a debriefing session. Students were given a pre- and post-simulation written examination and survey. Eighteen students enrolledin the Acute Care Therapeutics (ACT) elective completed anadditional simulation the following week without any additionalformalized instruction. ACT students were reassessed for clinicalperformance and by written examination. RESULTS: During the initial simulation, third-year pharmacystudents successfully completed 77% of the ACLS clinical tasks.Performance improved in the ACT group from 71% to 95% during thefirst attempt and retest, respectively. The written examination classaverage improved from 97% on the pretest to 99% on the initialposttest. Written examination scores initially improved for the ACTgroup (91.7% pretest vs. 98.6% posttest), but declined duringreassessment the following week (86%).


CONCLUSION: Repetitive ACLS simulation-based learningexperiences improved pharmacy student clinical performance, butfailed to improve knowledge retention for written examination. Presented at the Annual Meeting of the American Association ofColleges of Pharmacy, San Antonio, TX, July 9–13, 2011.

311. Evaluation of a 20-week longitudinal student program. KellyM. Wright, Pharm.D., Amy L. Dzierba, Pharm.D.; NewYork-Presbyterian Hospital, New York, NY PURPOSE: Schools of Pharmacy develop relationships with practicesites to provide students with advanced practice experiential rotationsto assume direct patient care responsibilities. A typical student willhave 7-9 rotation sites. NewYork-Presbyterian (NYP) has collaboratedwith Saint John’s University School of Pharmacy to provide fifth-yearpharmacy students with five, 4-week rotations in a longitudinalfashion. The 20-week student program at NYP is intended to exposethe student to various aspects of clinical pharmacy within a largelydiverse patient population under the direct guidance of a preceptor. METHODS: In order to build more effective programs to enhancestudent achievement, an evaluation of the current process wasimplemented. Information including grade point average (GPA),professional involvement, work experience, and a 10-item evaluationof the program was collected. In addition, a one year follow-up emailwas sent to determine which career path the student pursued. RESULTS: Thirteen students were consented and enrolled. Accordingto student report, 8 and 13 received Honors and 4 and 10 were HonorSociety members during high school (HS) and pharmacy schoolrespectively. Nine students held a Professional Membership.Pharmacy GPA was >3.1 in twelve students. The majority of studentsworked in a retail setting and reported 2-4 years of pharmacy workexperience. There were eleven responders for the 10-item survey. Tenstudents agreed or strongly agreed that the longitudinal program atNYP made them more likely to pursue a Pharmacy Residency. At 1-year there were nine responders, eight students had accepted aPharmacy Residency position and one accepted a job in retail afterfailing to match. CONCLUSION: All students were high professional achievers in HSand pharmacy school. It’s unknown whether the student participantsaccurately represent the general student population; however per self-report they identified the longitudinal program as a positive influenceto pursue a Pharmacy Residency.

312. Creation of a global health pharmacy residency in Kenya.Monica L. Miller, Pharm.D., M.S., Rakhi Karwa, Pharm.D., Ellen MSchellhase, Pharm.D., Sonak D. Pastakia, Pharm.D., M.P.H., ImranManji, B.Pharm.; Purdue University, Indianapolis, IN PURPOSE: Clinical pharmacy services continue to advance in theUnited States and abroad. Despite these advances, a shortage ofclinically trained pharmacists exists in developing countries. Toaddress this need, Purdue University College of Pharmacy (PUCOP)through its Purdue Kenya Program (PKP) developed a pharmacyresidency program in Kenya entitled the Clinical Pharmacy ResidencyExchange Program (ClinPREP). Since 2004, PUCOP has collaboratedwith the Academic Model for Providing Access to Healthcare(AMPATH) to provide clinical pharmacy services. AMPATH and PKPare based in Eldoret, Kenya and provide care to more than 120,000patients at more than 50 clinic locations throughout Western Kenya. METHODS: ClinPREP is an international pharmacy residencyprogram with a focus on training participants to be global health carepractitioners who are able to provide leadership in resource-constrained settings worldwide. The residency class is comprised ofAmericans and Kenyans allowing for a bilateral exchange ofexperiences and ideas. The program’s main goal is to train clinicalpharmacists who can develop and deliver sustainable health careregardless of the setting. The ClinPREP framework was developed inpart by using the ASHP residency standards and identifying additionalglobal health related training needs of participants. The residentsparticipate in a variety of established clinical services and as a groupare developing a new, sustainable clinical service. In addition todeveloping clinical skills, residents receive didactic training in publichealth, research methodology, and preceptor development. Residentsalso strengthen their teaching skills while precepting PUCOPadvanced pharmacy practice experience students and Kenyan

pharmacy interns. RESULTS: The program began in July 2011 with 4 participants. Theresidents are working to develop a new clinical service to augmentpatient care. CONCLUSION: The ClinPREP residency program addresses a needfor developing clinical pharmacy services in Kenya while trainingglobal health leaders from Kenya and America.

313. Expanding residency opportunities through school ofpharmacy collaborations. Heather J. Johnson, Pharm.D.1, Amy L.Seybert, Pharm.D.2; (1)UPMC Department of Pharmacy andTherapeutics, Pittsburgh, PA; (2)University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: In 2011 over 1300 candidates did not match with the2500 positions offered. Residency training as a requirement for directpatient care will likely increase the number of candidates. The demandfor expansion of pharmacy residency programs and the challenge ofexpanding while maintaining quality is shared throughout ourprofession. Schools of Pharmacy can contribute to the expansion ofpharmacy residency training . We describe the nature and impact ofthe University of Pittsburgh School of Pharmacy’s collaboration withlocal residency programs and health systems on the growth andcontent of residency programs. METHODS: Areas of contribution include development of learningopportunities, program sponsorship, and residency programcollaboration. RESULTS: Program Development: A suite of faculty-basedlongitudinal programs were developed for residents including adidactic and practical research series and teaching certificate program.Developed to enhance the quality of resident research and offer astructured framework, the research series is a required component for18 residencies collaborating with the University of Pittsburgh Schoolof Pharmacy. The elective teaching mastery program, completed by 43residents to date, offers specialized and advanced opportunities forresidents. Residency Sponsorship: Strategic planning identified keyareas for development of residencies. Sponsorship from third partyorganizations as well as the School directly has led to the developmentof pharmacy residencies that are now self-sustaining. ProgramCollaboration: Program directors and School faculty form a ResidencyCouncil which collaborates on common issues. This group providesprogram directors guidance during residency development as well aspeer review of new programs. This spirit of collaboration has enabledus to guide the development 5 new residencies in the last 4 years. CONCLUSION: Schools of pharmacy can provide resources for thedevelopment of residents in various ways and should exploreopportunities in their sphere of influence in order to facilitateresidency growth.

314. Utilization of cloud computing to aid experiential preceptingat a tertiary academic medical center. Maria Giannakos, Pharm.D.,M.B.A., Timothy Pasquale, Pharm.D.; Summa Health System - AkronCity Hospital, Akron, OH PURPOSE: The demand for experiential sites and preceptors hasincreased as a result of the growth of existing pharmacy programs andthe increase in new colleges of pharmacy. Similarly, the number ofgraduates pursuing residency training has also impacted the need foradditional residency opportunities and associated resources.Utilization of Google’s cloud computing platform is one potentialapproach to consolidating rotation resources to maximize preceptingtime, further enhancing the learning experience. METHODS: A shared website was created using Googleinfrastructure. General rotation information on the rotation site,expectations, and required reading assignments were posted forviewing. Prior to topic discussions, trainees performed literaturesearches and posted at least one article citation and/or link which thetrainee found most useful. Completed assignments or drafts could beposted for the preceptor to retrieve, allowing off-campuscollaboration. Additionally, a shared Google calendar was createdwithin which both parties would add appointments and deadlines in amerged calendar. Useful web links, some institution-specific, werealso incorporated to facilitate learning. RESULTS: Two preceptors utilized the shared site for separaterotations in a similar, yet unique precepting experience. Seven

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Pharm.D. candidates and three residents were granted access to thesite over one year. The shared site consolidated resources andenhanced communication. An additional benefit seen was that ofunlimited storage space and emailing capacity. CONCLUSION: The utilization of cloud computing enhanced theorganization of resources and augmented the precepting experience.Overall, on-demand electronic access to shared resources wasbeneficial to both preceptor and trainee.

315. Pharmacist-physician interdisciplinary faculty development:Get out of your silo!. Trish Klatt, Pharm.D., BCPS1, Heather A.Sakely, Pharm.D., BCPS1, Stephen A. Wilson, M.D., M.P.H., FAAFP2;(1)UPMC St. Margaret, Pittsburgh, PA; (2)University of PittsburghFamily Medicine Faculty Development Fellowship UPMC StMargaret Family Medicine Residency, Pittsburgh, PA PURPOSE: Innovative pharmacy resident curriculum is cultivatedthrough a multidisciplinary approach to teaching. METHODS: The Faculty Development Fellowship for familymedicine physicians at UPMC St. Margaret has been established for30 years. Eight years ago, our pharmacy residency started with 1resident and since, the residents have participated in this fellowship,creating a novel learning experience. The curriculum consists of asummer intensive series of small group workshops, 4 half-days perweek for 6 weeks. A longitudinal series then begins for one-half dayper week throughout the year. The curriculum consists of 4 main topicareas: teaching and learning, leadership, research, and communicationand professional writing. RESULTS: The teaching and learning component focuses onprecepting learners of all types, curriculum design, didactic teachingstrategies, providing feedback to learners, and adult learning theory.Pharmacy residents and physicians work together to design andpresent a hands-on multidisciplinary, longitudinal curriculum to thephysician and pharmacy residents throughout the year. Leadershipskills are cultivated through this task, which has included themes ofend of life care, new health care system, or some other facet ofsystems based health care. A database research study is oftencompleted by participants and the pharmacy resident’s personalresearch project is regularly discussed. Fellowship participants writeand publish a letter to the editor, allowing an opportunity forprofessional writing and literature evaluation. Active discussion andfeedback from another discipline helps the author to shape and designtheir writing. They also express themselves through 55-word storiesabout patient encounters, and gain skills interacting with the mediaand for grant writing. CONCLUSION: Pharmacy residents and physicians in the fellowshipoften go on to academic positions. They are well positioned to holdleadership roles in professional organizations and serve as professionalmentors.

316. Critical literature evaluation and advanced pharmacypractice experiences: student preparedness. Kathryn M. Momary,Pharm.D., Lisa M. Lundquist, Pharm.D., BCPS; Mercer UniversityCollege of Pharmacy and Health Sciences, Atlanta, GA PURPOSE: Compare students’ performance and perceptions ofpreparedness to critically evaluate literature before and after advancedpharmacy practice experiences (APPE). METHODS: A perception of preparedness questionnaire and aknowledge assessment were distributed to the students in the thirdprofessional year (before APPE) and in May of the fourth professionalyear(after APPE) for two consecutive classes. The knowledgeassessment and preparedness instrument consisted of questions relatedto core knowledge and application of critical literature evaluation.Students were asked to rate the adequacy of their preparedness on a 4-point Likert scale with 1 = extremely unprepared, 2 = unprepared, 3 =prepared, and 4 = extremely prepared. Knowledge assessment wasdone via an 8-question multiple choice quiz. Data collection for thisstudy was approved by the IRB and students signed informed consentprior to participation. Students’ perceptions of preparedness andperformance before and after APPE were compared with descriptivestatistics and Pearson’s correlation; pre- and post-APPE data werecompared with paired t-test. RESULTS: One hundred forty-two students (50%) consented forparticipation and completed all pre- and post-APPE perception of

preparedness questionnaires and knowledge assessments before andafter APPE. The perception of preparedness mean (SD) increasedsignificantly from 2.2 (0.5) pre-APPE to 3.0 (0.4) post-APPE[p<0.001]. Knowledge assessment also increased significantly from56.3% (19.0%) pre-APPE to 63.3% (16.6%) post-APPE [p=0.001].There was a statistically significant correlation between the pre- andpost-APPE knowledge assessment and perception of preparedness(p<0.001 and p<0.001, respectively). CONCLUSION: Students’ perceptions of preparedness andknowledge of critical literature evaluation statistically significantlyimproved after clinical experiences in APPE. However, studentknowledge is still not optimal. APPE provide an invaluableopportunity to reinforce and expand knowledge of literatureevaluation and its importance as a practicing pharmacist. Increasedreview of critical literature evaluation during APPE will likely furtherimprove student performance.

Emergency Medicine

317. A retrospective review of medication orders entered foremergency department patients within an academic teachingmedical center for quality assurance. Jason W. Lancaster, Pharm.D.,BCPS; Northeastern University: Department of PharmacyPractice/Lahey Clinic Medical Center, Boston, MA PURPOSE: Currently the Joint Commission recommends that theDepartment of Pharmacy prospectively review all medication ordersfor patients within the emergency department (ED), and if not, thatdocumentation that quality assurance measures performed anddocumented. At this time the Lahey Clinic Medical CenterDepartment of Pharmacy has no baseline data surrounding theappropriateness of patient administered medications within theemergency department. METHODS: Using a random numbers table patients were selectedfrom the daily admissions to the emergency department during themonth of December 2010. Patients were included if they wereadmitted to the ED, >18 years old and had at least one medicationordered. RESULTS: A total of 128 patients were identified, and 100 wereincluded. The mean age of those included was 56.8 years and a total of248 orders were evaluated, providing an average of 2.5 orders perpatient. Of the 248 orders evaluated 231 (93.1%) would have requiredno further intervention based on a retrospective pharmacists review.However, 17 orders (6.9%) would have and the reasons forintervention include subtherapeutic dosing, duplication of drug classesprescribed, or inappropriateness of route, frequency or dose. CONCLUSION: From this review it was determined that a majorityof the orders written and administered in the emergency departmentwould have required no further pharmacist intervention and wouldhave been entered directly into the pharmacy medicationadministration system. However, in approximately 7% of these ordersadditional pharmacist review may have led to optimization. Of these,the largest percentage involved antibiotic, pain medication and anti-emetic agents. Although the impact of pharmacist prospective reviewand intervention cannot be fully known from this study there wereclear areas identified where a pharmacist prospective review ofmedication orders may have led to increased compliance to hospitalprotocol(s), reduction in costs and avoidance of duplicativemedication classes and further evaluation is warranted.

318. Implementation and evaluation of a recombinant activatedfactor VII guideline for uncontrolled bleeding. Nicole M. Acquisto,Pharm.D., Paul E. Bankey, MD, Ph.D., Curtis E. Haas, Pharm.D.;University of Rochester Medical Center, Rochester, NY PURPOSE: Recombinant activated factor VII (rFVIIa) has been usedfor patients with uncontrolled bleeding without hemophilia. There aremultiple controversies concerning indication, dose, adverse effects,and exclusion criteria. Due to cost and limited evidence of value, needfor standardization of use is evident. METHODS: An inter-professional group that included pharmacy andseveral surgical specialties was formed. Current literature wasreviewed and peer institutions were queried for identification of best-practices. The guideline was developed and included indications foruse, inclusion criteria for coagulopathic bleeding, exclusion criteria


for futility and risk of thromboembolic complications, dose, andrelative contraindications. All patients receiving rFVIIa prior toguideline implementation and after were monitored. RESULTS: Overall, 70 doses of rFVIIa were administered to 59patients prior to protocol implementation (2005 to July 2008) and 95doses to 68 patients following protocol implementation (August 2008to 2010). The median dose (IQR) in the pre-protocol group was 90µg/kg (43.75 to 93 µg/kg) and 26.25 µg/kg (20 to 40 µg/kg) in thepost-protocol group, p<0.001. Although lower doses were evidentfollowing guideline implementation, there was no difference in in-hospital mortality, 49% vs. 45.6% in the pre- and post-protocolgroups, respectively, p=0.55. An evaluation of guideline exclusioncriteria found that a higher percentage of patients met at least oneexclusion criteria in the pre-protocol group compared to the post-protocol group, 57.6% vs. 29%, respectively, p=0.001. Exclusioncriteria were often a low platelet count at the time of rFVIIaadministration without administration of additional platelets. CONCLUSION: rFVIIa dose has decreased appreciably without anapparent negative effect on mortality. The proportion of patientsreceiving rFVIIa that have meet exclusion criteria continues todecrease following protocol implementation. This is likely a directimpact of the protocol and the result of regular feedback to theproviders.

319. Benchmarking enoxaparin use in the emergency departmentas a quality improvement metric for clinical pharmacy services.Matthew S. Nelson, Pharm.D., Natasha D. Lopez, Pharm.D., CandiceR. Preslaski, Pharm.D., Elena Santayana, Pharm.D., BCPS, Ishaq Lat,Pharm.D., BCPS; University of Chicago Medical Center, Chicago, IL PURPOSE: To determine the appropriateness of enoxaparin use inthe emergency department and to quantify the financial impact ofdispensing a single size of enoxaparin from the medication dispensingcabinet as an opportunity for continued quality improvement. METHODS: A drug utilization review was conducted on patientswho received enoxaparin in the emergency department during a 3-month period from April to June 2010. Each dispensing of enoxaparinwas then compared to the administered dose and was evaluated for theamount of waste generated by the difference between the dispensedand administered doses. The orders were also evaluated by apharmacist to assess the appropriateness of therapy taking into accountthe indication, weight, renal function, and any anti-Xa levels drawnfor the patient. Appropriateness was determined as adherence to themedical center’s enoxaparin policy. RESULTS: Of the 124 enoxaparin orders during the 3-month period,thirty-two were dosed for prophylaxis and 92 were dosed fortreatment. All 32 prophylaxis doses were deemed appropriate. Of the92 treatment doses, fifty-two (56.5%) were deemed appropriate, and40 (43.5%) were deemed inappropriate, as determined by medicalcenter policy. The use of a single syringe size resulted in the aggregatewaste of 3,569 mg of enoxaparin during this 3 month period. Thiscorrelates to an estimated cost of $1,446.39, which would translate toan annual cost of $5,785.56 from enoxaparin waste. Continueddispensing of inappropriate doses after hospital admission wasted anadditional 3,060 mg of enoxaparin. This correlates to an estimatedadditional cost of $1,145.37 over the 3-month period, or $4,581.48annually from enoxaparin wastage. Combined, the estimated annualcost from enoxaparin wastage was $10,367.04. CONCLUSION: This study serves as a benchmark metric for qualityimprovement in the provision of emergency medicine clinicalpharmacy services.

320. Evaluation of a pharmacist oversight program for medicationuse in the emergency department of an academic medical center.Sally Rafie, Pharm.D., Theodore Chan, M.D., Edward Castillo, Ph.D.,Douglas Humber, Pharm.D., Ronald Dunlay, Pharm.D.; UC San DiegoHealth System, San Diego, CA PURPOSE: The objectives of this study were to assess the impact ofpharmacist oversight of medication use in the ED on patient safety andstaff acceptance of the new service. The pharmacist oversight programincluded review of all medication orders; however, the ED staff couldremove medications from the automated dispensing cabinet viaoverride. METHODS: The study was conducted at an academic medical center

with 61,000 ED visits annually. Retrospective data between April andAugust 2010 was reviewed. Reported medication errors and EDpharmacist interventions were analyzed for trends and pharmacistimpact. To assess ED physician and nursing satisfaction with the EDpharmacist program, an anonymous survey was conducted one yearafter program initiation. RESULTS: During the five month period, 361 medication errors weredocumented. The most common errors included overriding theautomated dispensing cabinets (ADC) without a provider order (73%),wrong dose/infusion rate (18%), wrong drug (8%), and wrong patient(4%). A total of 244 pharmacist interventions documented, with anacceptance rate of 83.2%. Faculty, residents, and nurses completed theanonymous survey (n=79, 40.1% response rate). Staff agreed that theED pharmacist was beneficial in assisting with drug informationquestions (95.9%), medical resuscitations/codes (93.2%), and patienteducation (89.0%). Only a small portion of respondents noted that allED medication orders (17.8%), urgent orders (16.4%) or non-urgentorders (19.2%) should be reviewed; whereas the majority ofrespondents noted that orders for high risk medications (78.1%) andrarely used medications (72.6%) should be reviewed by a pharmacist.Respondents felt ED pharmacists being available for consult andattending resuscitations/codes maximized their contribution tomedication safety. CONCLUSION: The results suggest that pharmacist oversight ofmedication use in the ED reduces medication errors, reducing the riskof patient harm and increasing patient safety.

Endocrinology

321. Adjunctive sitagliptin therapy in postoperative cardiacsurgery patients: a pilot study. Marcia L. Brackbill, Pharm.D.,BCPS1, Ateequr Rahman, Ph.D., MBA1, Jeffrey Sandy, RN2, M.Denton Stam, M.D.3, Arthur F. Harralson, Pharm.D., BCPS1;(1)Shenandoah University, Bernard J. Dunn School of Pharmacy,Winchester, VA; (2)Winchester Medical Center, Winchester, VA;(3)Valley Health Cardiothoracic and Vascular Surgeons, Winchester,VA PURPOSE: Adequate blood glucose control after cardiac surgery isoften challenging for clinicians in the postoperative setting. Due itsnovel mechanism of action and its lack of serious side effectscompared to other oral antihyperglycemic agents, sitagliptin is an idealmedication to evaluate in this setting as an adjunctive therapy. Thisstudy sought to determine if sitagliptin added to standardpostoperative blood glucose management improved mean overallblood glucose control in the four-day period after cardiac surgery. METHODS: A single center, prospective, randomized, double blindplacebo-controlled pilot study was conducted in 62 hospitalizeddiabetic patients who underwent cardiac surgery. Patients receivedsitagliptin 100 mg once daily or a matching placebo after surgery for 4days. The primary objective was to estimate the effect of adjunctivesitagliptin administration on overall mean blood glucose in the 4-dayperiod after initiation of sitagliptin therapy compared to standardblood glucose management practices alone. RESULTS: Sixty-two patients participated in the study, and wererandomly assigned to the sitagliptin or placebo group (n=30 and 32,respectively). Baseline analysis revealed no statistical differencesbetween the treatment groups and control groups in demographics andbaseline parameters. The repeated measures test indicated that therewas no significant difference between the two groups in the overallmean blood glucose level with a mean of 147.2±4.8 mg/dL and153.0±4.6 mg/dL for the test and the control group, respectively(p=0.388). CONCLUSION: Sitagliptin added to normal postoperative glucosemanagement practices did not improve overall mean blood glucosecontrol in diabetic patients in the postoperative cardiac surgery setting.

Family Medicine

322E. Incorporating pharmacy services within a family medicineresidency home visit program. Tanya M. Dougherty, Pharm.D.,BCPS1, Heather A. Klusaritz, MSW2, Peter F. Cronholm, MD, MSCE2,Nishaminy Kasbekar, BS, Pharm.D., FASHP3; (1)Penn PresbyterianMedical Center, Department of Family Medicine and Community

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Health, University of Pennsylvania, Philadelphia, PA; (2)Departmentof Family Medicine and Community Health, University ofPennsylvania, Philadelphia, PA; (3)Penn Presbyterian Medical Center,Philadelphia, PA PURPOSE: To evaluate patient-related medication and safetyoutcomes associated with pharmacist and pharmacy studentinvolvement in a family medicine residency home visit program. METHODS: The home visit team at the University of PennsylvaniaFamily Medicine Residency consists of an attending, residentphysician, social worker and pharmacist and/or pharmacy student.Patients are deemed appropriate home visit candidates for evaluationof: post-hospitalization/acute care follow-up, medicationassessment/reconciliation, long-term care options, or environmentaleffect on illness. The pharmacy team evaluates medication takinghabits at home, conducts medication reconciliation, providescounseling on adherence and medication use and recommendsmedication changes based on safety/efficacy concerns. Data on visitreason, adverse events, drug-related problems () and interventions wasanalyzed. RESULTS: Out of 48 patients visited, reasons for home evaluationwere medication assessment (41%), post-hospitalization (31%),environment (21%), options (6%), other (3%). The pharmacy teamidentified 79 (mean 1.9/patient; range 1–7), the most common beingadherence issues (52%). Others included overuse, underuse, taking amedication that was stopped, taking expired medications, duplicatetherapy, low health literacy, incorrect administration, taking amedication to which an allergy exists, and side effects. Of those , 13preventable adverse events () were identified and solved withpharmacy recommendations in 12 patients (27%). The were:continuing to take medications (, ) stopped due to adverse event (GIbleed, hypotension), taking lower or higher than prescribed doses (,insulin), duplication (), drug interaction necessitating change intherapy, crushing ER medications ( acid, ), patient allergic to sulfarecently started with new rash. A total of 30 pharmacy interventionswere accepted including discontinuing medications, reducing cost ofmedications, delivery set-up, teaching, switching medications. CONCLUSION: Involvement of a pharmacist and pharmacy studentswithin a family medicine residency home visit program can reducedrug-related problems and preventable adverse drug events.Presented at To be presented at Annual Meeting and Exposition of thethe American Public Health Association, Washington, D.C, October29–November 2, 2011.

323. COPD free medication initiative. Jennie Broders, Pharm.D.,BCPS, Patricia Klatt, Pharm.D., BCPS, Isabel MacKinney-Smith,BSN, RN; UPMC St. Margaret, Pittsburgh, PA PURPOSE: Financially, COPD is an extreme burden for patientsseeking to pay for multiple expensive inhalers as well as thehealthcare system due to hospital readmission rates. The University ofPittsburgh Medical Center (UPMC) - St. Margaret has the secondhighest 30-day COPD readmission rate within UPMC. In an effort toreduce readmission rates, a COPD task force has been formed. Thisgroup of nurse educators and case managers identifies COPD patientsrecently discharged and performs follow-up phone calls and homevisits to improve patient and family education, subsequentlydecreasing readmission. Inability for many patients to obtain theirinhaled medications for COPD has been identified by the task force asa major contributor to readmissions. METHODS: UPMC has a charitable mission to provide medicallynecessary health care services to residents of Western Pennsylvaniaand its providers’ primary service areas, regardless of their financialstatus and ability to pay. In accordance with this mission, UPMC St.Margaret’s 3 family health centers have successfully offered a FreeMedication Program to provide acute and maintenance medication tothose patients who would otherwise be unable to afford them. Theonly COPD medications available through this program are albuteroland a steroid inhaler. Through this established Free Medicationprogram system and network of COPD educators, UPMC St. Margaretproposes availability of COPD medications to all patients that areunable to afford them in UPMC St. Margaret Family Medicinepractices. We will expand the formulary to include anticholinergicmedications and long-acting beta agonists in order to optimize thetreatment of COPD. Currently there are no generic inhalers indicated

for the treatment of COPD, inherently incurring large costs for thistype of program. However, we hypothesize that the cost of inhalermedication supply would be far less than readmission costs.

Geriatrics

324E. Characteristics associated with clinical pharmacistinterventions among home based primary care veterans. JenniferT. Selvage, Pharm.D., Liancy Gomez, Pharm.D., AnnetteKossifologos, Pharm.D., Tripti Kurup, Pharm.D., Kavita Palla,Pharm.D., Todd Lee, Ph.D., Pharm.D.; Edward Hines, Jr. VA Hospital,Hines, IL PURPOSE: Determine patient characteristics associated with a highnumber of clinical pharmacist recommendations at home visits amonghome based primary care (HBPC) veterans. METHODS: HBPC patients with a pharmacist home visit between7/2009-10/2010 were identified. Characteristics obtained from chartswere: demographics, medical conditions, medications, reason forpharmacist home visit, and use of non-VA providers. The number ofpharmacist recommendations made from the following categories wasdetermined: use of pillboxes, medication management process,medication commissions and omissions, possession or use ofdiscontinued or expired medications, noncompliance, incorrectmedication use or storage, potential drug-drug/disease interactions,and reported adverse drug reactions. Patients with a high number ofrecommendations (>7 recommendations) were compared to those withfewer recommendations. Bivariate comparisons were made betweengroups and logistic regression was used to estimate adjustedassociations between patient characteristics and a high number ofrecommendations. RESULTS: 62 patients had home visits. A total of 742 medicationrelated issues were identified, resulting in 338 pharmacistrecommendations. Patients with a high number of recommendationshad, on average, 4 more medications than those with fewerrecommendations (p=0.02). Factors associated with a high number ofrecommendations included use of lipid lowering medications [(OR)7.3, 95% CI 0.9–60.2], GERD (OR 3.4, 1.1–11.3), number ofmedications (OR 1.1, 1.0–1.3), and medication self-management (OR6.7, 1.7–27.0). Presence of hyponatremia and use of antiplateletmedications were perfectly predictive of a high number ofrecommendations. In adjusted analyses, medication self-managementremained significantly associated with a 6-fold increase in thelikelihood of being in the high recommendation group (Adj OR 6.0,1.3–26.8). Of the pharmacist recommendations made, 63.6% wereaccepted. CONCLUSION: Patients who self-manage medications, those with agreater number of medications, and those with lipid loweringmedications, antiplatelet agents, GERD, or hyponatremia may benefitmost from a pharmacist home visit. Presented at Presented at the American Geriatric Society AnnualScientific Meeting, National Harbor, MD, May 11–14, 2011.

325. A pilot fee-for-service medication therapy managementprogram in a geriatric primary care clinic. Sunny A. Linnebur,Pharm.D., FCCP1, Joseph P. Vande Griend, Pharm.D.1, Gina Moore,Pharm.D., MBA1, Irene Girgis, Pharm.D.2; (1)University of ColoradoSchool of Pharmacy, Aurora, CO; (2)Colorado Access, Denver, CO PURPOSE: To describe the development and implementation of apilot medication therapy management (MTM) program reimbursed asa fee-for-service through Medicare METHODS: A contract was negotiated between the University ofColorado School of Pharmacy to provide MTM services as coveredbenefits for all of the Geriatric Primary Care Clinic patients enrolledin the Medicare Advantage HMO plan sponsored by Colorado Access,a non-profit insurance provider. Two clinical pharmacists, with anestablished relationship with clinic providers and full access to theelectronic medical record (EMR), provided the services.Unreimbursed MTM services have been provided at the clinic for over10 years. MTM was performed face-to-face and over the phone. Thenumber of billable visits was not limited. To aid in the MTM visits,the clinical pharmacists were allowed access to prescription claimsdata by Colorado Access. Changes to the patient’s pharmacotherapyregimen were made in concert with the patient’s healthcare provider


and focused on: 1) medication reconciliation; 2) identification andresolution of drug-therapy problems, including non-adherence; 3)cost-saving through formulary management; and 4) patient-specificdisease state and drug therapy education. RESULTS: Cognitive services (CPT codes 99605, 99606) and facilityfees (99212, 99214) were remitted for payment. MTM services werereimbursed at a flat rate based on the visit type. During 2010, theservice was offered to 68 members, 42 of whom met with a clinicalpharmacist for at least one MTM visit. CONCLUSIONS: Full access to the EMR and prescription claimsdata allowed the pharmacists to provide high-level drug therapyrecommendations. Having established relationships with clinicproviders likely contributed to a high documented implementation ratefor recommendations. For 2011, the contract was renegotiated fortiered reimbursement, based on the time and complexity of the visit,and was expanded to three additional clinics within the Universitysystem.


326. Initial stages in the development of an antimicrobialstewardship program in a teaching hospital. Ashley R. Hughes,Pharm.D.1, Michael C. Ott, Pharm.D., BCPS2, Randy A. Gerwitz,R.Ph.2, Joseph A. Paladino, Pharm.D.3, Gina M. Prescott, Pharm.D.,BCPS1; (1)University at Buffalo, Amherst, NY; (2)Erie CountyMedical Center, Buffalo, NY; (3)CPL Associates LLC, Buffalo, NY PURPOSE: Literature detailing the significance of an antimicrobialstewardship program (ASP) in healthcare facilities is robust. However,descriptive plans illustrating the development of an ASP in thehospital setting is limited and will be addressed in this poster. METHODS: Utilizing the Infectious Disease Society of America(IDSA)/Society of Healthcare Epidemiology of America (SHEA)guidelines, formulation of an ASP at Erie County Medical Center(ECMC) focused on initial development of a team, antimicrobial use,infection control and environmental services. Hospital policies andstrategies such as intravenous to oral therapy conversion, antibioticstreamlining and de-escalation were then implemented. A proposal toreview the impact of interventions was also designed. RESULTS: Aspects of the ASP that have been created and put intopractice as well as plans for future development of ASP at ECMC areillustrated. Specifically, successes and challenges encountered whiledeveloping the ASP, such as barriers in implementing policies as wellas strategies taken to utilize existing resources at ECMC, arehighlighted. CONCLUSION: Building an ASP is a stepwise process and overtimeprogression can occur. These techniques presented can be utilized toassist with the growth and development of ASPs in other healthcarefacilities.


327. A comparative evaluation of single fixed-dosing and weight-based dosing of rasburicase for tumor lysis syndrome. SherrieLathon, Pharm.D., Leigh Boehmer, Pharm.D., Sara Butler, Pharm.D.,Kristan Augustin, Pharm.D., Ali McBride, Pharm.D., M.S.; Barnes-Jewish Hospital, St Louis, MO PURPOSE: The purpose of this study was to evaluate rasburicasedosing strategies utilized at one institution to determine the minimumrasburicase dose required to manage hyperuricemia secondary totumor lysis syndrome. METHODS: This retrospective chart review was conducted betweenJanuary 1, 2005 and February 18, 2011. Adult patients who received atleast one 3 mg, 6 mg, 7.5 mg or weight-based dose were included.Tumor lysis laboratory data were recorded and monitored up to 72hours after initial rasburicase dosing. Cancer diagnosis, concomitantmedications known to increase hyperuricemia risk, and tumor lysisrisk factors were collected and analyzed. Treatment success wasdefined as a normalized plasma uric acid level (< 7.5 mg/dL) within24 hours after receiving rasburicase. RESULTS: Three hundred and seventy-three patients were evaluated;3 mg (n = 38); 6 mg (n = 99); 7.5 mg (n = 43); weight-based (n =193). The mean weight-based dose utilized was 0.17 mg/kg. Medianbaseline plasma uric acid levels were 6.85 mg/dL (interquartile range

5.68–8.4), 8.80 mg/dL (7.75–10.8), 8.00 mg/dL (5.0–10.0) and 9.20mg/dL (6.7–11.9). There were a total of 7 rasburicase treatmentfailures; 3 mg (n = 2); 6 mg (n = 1); 7.5 mg (n = 0); weight-based(n=4). At 24 hours post-rasburicase administration, there was nostatistically significant difference between groups in achieving anormalized plasma uric acid level (92.9% vs 97.6% vs 100.0% vs98.0%, p=0.190). CONCLUSION: The efficacy of single fixed dosing and weight-based dosing strategies evaluated in this study appear to becomparable in normalizing plasma uric acid levels within 24 hours ofrasburicase administration. Utilization of a 3 mg rasburicase dose isthe most cost-effective treatment strategy in managing hyperuricemiasecondary to tumor lysis syndrome. Further analysis of patient-specific factors will be conducted in those requiring repeat dosingwith rasburicase.

328. Evaluation of an improved warfarin dosing guideline used byan inpatient pharmacy-managed anticoagulation servicecompared to physician’s dosing. Mandana Ghodrat, Pharm.D.1,Laleh Azari, Pharm.D.2, Gregory Smallwood, Pharm.D.1;(1)Philadelphia College of Osteopathic Medicine - School ofPharmacy, Suwanee, GA; (2)Methodist University HospitalDepartment of Pharmacy, Memphis, TN New models of inpatient anticoagulation services provided bypharmacists have resulted in improved patient outcome throughreduction in number of adverse drug events. The success of theservices depends on individualization of therapy through welldesigned warfarin dosing guidelines and careful monitoring of thepatients. We developed an improved patient specific dosing guidelinefor management of patients receiving warfarin by pharmacists andthen compared outcomes to physicians’ management of warfarin. PURPOSE: The objective of this study is to evaluate a patient-specific warfarin dosing guideline used by an inpatient pharmacy-managed anticoagulation service compared to physician’s dosing. METHODS: This is an IRB approved, single-center, retrospectivechart review of hospitalized “warfarin-naïve” patients starting onwarfarin between January 2009 and May 2009. Data collected includepatient’s demographics, target INR, time on service, time to INR, timetherapeutic INR maintained, adverse events, drug interactions,education time, and dosing group. All data was evaluated comparingthree groups; pharmacists using guideline (RPh-Pro), pharmacists notusing guideline (RPh), and physicians (MD). RESULTS: Data on 125 patients were collected [RPh-Pro(n=58), RPh(n=22), and MD (n=45)]. Demographics were similar between allgroups (p=0.464) with group RPh having an older cohort (p=0.009).All 3 groups were similar in respect to INR target range (p=0.091),time on service(p=0.165), education time (p=0.318), and number ofpatients outside target INR by 0.5 (p=0.323) or 1 (p=0.490).Pharmacist using guidelines achieved INR quicker (3.8 vs 4.5 vs 4.4days; p=0.05) and maintained therapeutic INR longer (2.5 vs.1.9 vs1.2days; p=0.003) in a population having more drug-druginteractions(45% vs 36% vs 7%; p=0.001) with similarindications(p=0.091). CONCLUSION: Pharmacists using the dosing guideline for warfarinachieved therapeutic INR within a shorter period of time (p=0.05),maintained therapeutic INR longer (p=0.003) in a difficult toanticoagulate population. Based on these results, our institution hasadopted the pharmacy run warfarin dosing guideline for all patients onanticoagulation service.

329E. Evolution of an inpatient antithormbosis service includingadaptation to the EPIC system and workload assessment. WilliamDager, Pharm.D., Aaron Roberts, Pharm.D., Patricia Parker,Pharm.D., Richard White, M.D.; University of California, DavisMedical Center, Sacramento, CA PURPOSE: To describe the evolution of an inpatient anticoagulationservice (IPAS) and current paperless management approach withinEPIC at UCDMC. METHODS: The initial and current responsibilities/functions of theIPAS were explored. Time assessments were compiled randomly onselected daily activities of the service to describe a portion of thecurrent workload after going paperless in 2010. RESULTS: The initial responsibility of the service (1992) was to

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consult on the dosing of warfarin (approximately 1500 inpatientsannually, half were new to warfarin). In 2010 approximately 4700 newwarfarin starts occurred with 30 to 60 patients monitored daily.Current warfarin workload analysis observed a mean time of 14±5minutes for initial workup, 7±3 minutes for daily monitoring anddocumentation and 41 (range 31 to 51 minutes) for patient education.Monitoring direct thrombin inhibitors takes 12±9 minutes each day.The responsibilities and requests for assistance from the IPASincreased with advances in testing, availability of additional agents,expanded indications for anticoagulation, and desired to reduce relatedcomplications. The IPAS is also tasked with assisting and regulatingthe use of all parenteral anticoagulants and facilitating early homedischarge on bridging therapy when feasible and provide assistance inreversal strategies, anticoagulant agent selection and managementsupport. CONCLUSION: The IPAS has served as a beneficial resource andhas successfully been adapted to EPIC. The structure of inpatientanticoagulation care including the paperless system developed inEPIC to manage anticoagulation therapy along with the currentactivities and selected workload of the IPAS including unique servicesprovided by the IPAS at UCDMC will be described. Presented at Presented at the Anticoagulation Forum Conference,Boston, MA, May 5–7, 2011

Infectious Diseases

330. Development, implementation, and assessment of a pilotpharmacy vancomycin dosing service (PVDS). Andrea Pallotta,Pharm.D., Elizabeth A. Neuner, Pharm.D., BCPS, Jennifer K. Sekeres,Pharm.D., BCPS, Jeffrey Ketz, Pharm.D., BCPS, Jason Skok, ITD,Nabin Shrestha, M.D., M.P.H., FACP, FIDSA; Cleveland Clinic,Cleveland, OH PURPOSE: PVDS have effectively managed vancomycin (VANC)for decades. Now in the era of electronic medical records, we describeand evaluate a PVDS at a large, teaching hospital. METHODS: A PVDS was instituted on August 17, 2010 afterbuilding an electronic consult order, real-time alerts, patient lists, andtemplate notes. A retrospective chart review compared outcomes ofthe PVDS (RPh-group) to a pre-implementation control group (MD-group). Patients >18 years, on VANC and internal medicine teachingservices were included. Patients in the RPh-group who receivedVANC but were not consulted to the PVDS were excluded. Outcomesevaluated the number of VANC levels drawn and the proportion oflevels within the goal range. Timeframe was June 1 to July 31, 2010for MD-group and September 1 to November 31, 2010 for RPh-group. RESULTS: In the MD-group, 154 patients were enrolled and 116patients were enrolled in the RPh-group. No differences in baselinedemographics, weight, creatinine clearance. Most common indicationsfor VANC were pneumonia, soft-tissue and bacteremia in both groups.135 levels were drawn in MD-group versus 157 levels in RPh-group.The mean number of levels per patient was 2.11 and 2.15 in MD-group and RPh-group, respectively (p=0.88). A higher percentage oflevels (including trough and random levels) were within goal range inRPh-group (64%) compared to MD-group (52%, p=0.03). Of thetrough levels, 70% were within goal range in RPh-group compared to55% in MD-group (p=0.20). Overall physician satisfaction wasfavorable. CONCLUSION: Implementation of a PVDS utilizing the electronicmedical record resulted in more appropriate vancomycin dosingwithout increasing the number of vancomycin levels/patient drawn.

331. Incidence of supratherapeutic trough concentrations inelderly patients with aggressive vancomycin dosing. Nicole L.Metzger, Pharm.D., Faizan A. Mirza, Pharm.D., Kathryn M. Momary,Pharm.D.; Mercer University College of Pharmacy and HealthSciences, Atlanta, GA PURPOSE: There is limited data evaluating vancomycin dosing inthe elderly, especially when targeting a trough concentration of15–20mg/L. We conducted a retrospective, medical record review toevaluate the incidence of supratherapeutic trough concentrations inelderly patients who received aggressive vancomycin dosing (greaterthan 15 mg/kg/dose or Q12 hour dosing with CrCl less than 60ml/min) compared to conservative dosing.

METHODS: Patients at least 65 years who received at least 3consecutive treatment doses of intravenous vancomycin betweenJanuary 1, 2009–February 28, 2011 were included. Patients ondialysis, in the ICU, or without trough concentrations were excluded.Patients were stratified by vancomycin dosing regimen. The primaryoutcome was the rate of supratherapeutic trough concentrationsbetween the groups. Continuous and nominal variables were comparedbetween groups using Student’s t-test and chi squared, respectively. RESULTS: Data from 105 patient encounters were included in theanalysis. The majority of patients (69%) received aggressive dosingregimens. Mean age was similar between the groups (conservative71.2 years vs. aggressive 78.8 years; p=0.055). As expected, the meanvancomycin dose was higher in the aggressive group (aggressive 18.3mg/kg/dose vs. conservative 13.2 mg/kg/dose; 95% CI -6.21 to -4.00;p<0.001). The mean trough concentration was also higher in theaggressive group (aggressive 17.4mg/L vs. conservative 12.6 mg/L;95% CI -8.12 to -1.51; p=0.005). More supratherapeutic troughconcentrations occurred in the aggressive group compared to theconservative group (27.4% vs. 9.3%; p=0.031); however, theconservative group had more subtherapeutic trough concentrations(85% vs. 56.5%, p=0.023). Finally, there was no difference in theincidence of acute kidney injury (conservative 6.3% vs. aggressive10.96%; p=0.360). CONCLUSION: Aggressive vancomycin dosing in elderly patientsresulted in more supratherapeutic trough concentrations thanconservative dosing, while conservative dosing was associated withmore subtherapeutic trough concentrations. A specific dosingalgorithm for the elderly may need to be established.

332. Use of the clinical pulmonary infection score (CPIS) to guideduration of antibiotic therapy in medical intensive care unit(MICU) patients with healthcare-associated pneumonia (HCAP).Jill Jessmer, Pharm.D., Maribeth Pauli, Pharm.D. , Marina Yazdi,Pharm.D. , Mojdeh Saba, Pharm.D. , Claire Chan, Pharm.D.,Jonanthan Siner, M.D. , Jeffrey Topal, M.D. ; Yale-New HavenHospital, New Haven, CT PURPOSE: CPIS combines clinical, radiographic, physiologic andmicrobiologic data to systematically assess resolution of pneumonia.Scores of ≤ 6 on day 3 identify candidates for possible antibioticdiscontinuation. This study will determine if a pharmacist-ledantibiotic discontinuation policy using CPIS reduces duration ofantibiotic therapy in patients with HCAP. METHODS: Prospective data collection was performed as a baselinecomparison of antibiotic duration for HCAP at Yale-New HavenHospital. Patients ≥ 18 years of age admitted to the MICU on empiricantibiotic therapy for suspected HCAP were included. Duration ofantibiotic therapy was the primary outcome. Secondary outcomesincluded length of hospital and ICU stay and recurrence ofpneumonia. To detect a 2 day difference in treatment duration with80% and a type I error of 0.05, 78 patients are required in the pre- andpost-intervention groups. RESULTS: Of 40 patients evaluated, the mean age was 67 years andevenly distributed with respect to gender. Mean APACHE II score andCharlson Comorbidity Index were 15 and 3, respectively. Mean ICUand hospital lengths of stay were 8 days and 28 days. The ICUmortality rate was 7.5% with recurrent pneumonia occuring in 15% ofpatients. The mean duration of antibiotic therapy was 7 days, rangingfrom 3 to 15 days. On day 3, 80% of patients in the pre-interventiongroup had CPIS values of less than or equal to 6 which would haveidentified them as candidates for antibiotic discontinuation, potentiallyaverting 197 days of antibiotic therapy. CONCLUSION: Antibiotic therapy for HCAP patients in MICUpatients is routinely continued beyond clinical resolution.Implementation of a pharmacist-led antibiotic discontinuation policyusing CPIS has the potential to reduce unnecessary antibiotic use inpatients with HCAP which in turn would help to limit the developmentof antibiotic resistant flora in the ICU.

333. Sterol uptake in Candida albicans: a novel mechanism offluconazole resistance. Stephanie A. Flowers, Pharm., D.1, Sarah G.Whaley, B.S.2, Katherine S. Barker, Ph.D.1, P. David Rogers,Pharm.D., Ph.D.3; (1)University of Tennessee, Memphis, TN;(2)University of Tennessee College of Pharmacy, Memphis, TN;


(3)University of Tennessee Health Science Center, Memphis, TN PURPOSE: Azole antifungals exert activity by inhibitingbiosynthesis of the fungal membrane sterol ergosterol. InSaccharomyces cerevisiae, when endogenous sterol biosynthesis islimited, exogenous sterols can be used. These sterols are taken up byABC transporters Pdr11 and Aus1, which are both under the control oftranscription factor Upc2. It’s unclear whether Candida albicans takesup exogenous sterols under conditions that limit sterol biosynthesis.The purpose of this study was to determine if C. albicans can berescued from fluconazole treatment by providing exogenous sterolsand to determine the process by which this occurs. METHODS: A wild-type clinical isolate of C. albicans (SC5314) wassubjected to susceptibility testing for fluconazole in YPD in thepresence and absence of bovine serum (BS) as a source of exogenouscholesterol. Strains derived from SC5314 that were disrupted for thetranscription factor gene UPC2 or the putative sterol transporter geneCDR11 were likewise tested for changes in susceptibility tofluconazole. RESULTS: SC5314 exhibited a 24 hour MIC of 1µg/ml in YPD.Addition of %10 BS to YPD rescued C. albicans from the effects offluconazole resulting in an MIC of 64µg/ml. The upc2Δ/upc2Δ strainexhibited a fluconazole MIC of <0.5 µg/ml in YPD and in YPD with10% BS. The cdr11Δ /cdr11Δ strain exhibited a fluconazole MIC of1µg/ml in YPD and 8µg/ml in YPD with 10% BS.CONCLUSIONS: Our findings suggest that C. albicans can take upcholesterol from exogenous sources which can rescue it from theeffects of sterol biosynthesis inhibition by fluconazole. These effectsappear to depend upon the transcription factor Upc2 and partiallyupon the transporter Cdr11. These results represent a potentially novelmechanism of azole resistance in this pathogen and have significantimplications for susceptibility testing as the medium currently used forsuch testing doesn’t contain exogenous sterols.

334. Surveillance of antibiotic resistance at a tertiary institution inTrinidad. Patricia I. Sealy, Pharm.D., Ph.D.1, Madhura Manjunath,M.D.2; (1)The University of the West Indies,Faculty of MedicalSciences, School of Pharmacy, Port of Spain, Trinidad and Tobago;(2)Ministry of Health, Port-of-Spain, Trinidad and Tobago PURPOSE: Surveillance studies conducted by the Centers forDisease Control have demonstrated an alarming increase in resistancerates that impacted negatively on patient morbidity and/or mortalityand limited the use of antimicrobial agents. Surveillance is notcurrently conducted in Trinidad and Tobago, a developing country thatpractices universal health care. The selection of antimicrobial agentsfor inclusion on the national formulary should be based not only onefficacy data, but also on the prevalence of resistance at tertiaryinstitutions. We proposed to report the susceptibility data from atertiary hospital for the years 2009 to 2010 in order to monitor theselection and spread of resistant organisms. METHODS: In-patient clinical isolates (blood, respiratory, and urinecultures) that were processed between the years 2009-2010 from thetertiary hospital were reviewed. Clinical isolates were evaluated usingdisc diffusion method (zone sizes based on CLSI guidelines) andsusceptibility results were reported as percentages. RESULTS: Blood culture isolates: Klebsielia spp was consistentlyresistant (66%, 40s%) to amoxicillin-clavulanate and 3rd generationcephalosporins, respectively; Acinetobacter was resistant (50–90%and 50–70%) to 3rd generation cephalosporins and meropenem,respectively; ICU respiratory isolates: Klebsielia spp andAcinetobacter were consistently resistant (30–50% and > 50%) to 3rdgeneration cephalosporins, respectively. Urine cultures: Escherichiacoli was consistently resistant (38%) to co-trimoxazole. CONCLUSION: Waning susceptibility rates were observed for firstline antimicrobial agents that may be empirically administered.Consequently, clinicians should rigorously monitor resistance ratesand correlate observed trends with consumption patterns ofantimicrobial agents at each institution to ensure that selected agentsare susceptible. Appropriate recommendations (prescriber educationand antibiotic cycling) can, therefore, be made to preserve the efficacyof antimicrobial agents. Policy makers can also use this informationwhen making formulary decisions. Word Count - 282

Managed Care

335E. Improving documentation of the value of clinical pharmacyinterventions in an integrated healthcare delivery system. Sheryl J.Herner, Pharm.D., BCPS1, Robin R. Hill, Pharm.D., BCPS1, SamuelG. Johnson, Pharm.D., BCPS2, C. Ryan Lowe, Pharm.D., BCPS2, LeaC. Price, Pharm.D., BCPS3; (1)Kaiser Permanente, Aurora, CO;(2)Kaiser Permanente, Denver, CO; (3)Kaiser Permanente, Lafayette,CO PURPOSE: There is a continued challenge to document and validatethe financial impact of patient care provided by clinical pharmacyspecialists in ambulatory and acute care settings not directly related tomedication cost-avoidance. We sought to establish the financial impactof clinical pharmacy patient care interventions based on monetaryvalue derived from existing medication therapy management (MTM)reimbursement models, estimated cost avoidance literature, and anestimated physician-time offset model. METHODS: A workgroup was formed within Clinical PharmacyServices (CPS) to: (1) explore ways to capture the monetary value ofpatient care interventions (e.g., MTM, prevention of adverse drugreactions, outpatient clinic visits avoided, and physician time offset;(2) develop a tool to assist with documentation of these contributions;and, (3) foster accountability within 14 different specialty CPSpractices by engaging in small-group bi-weekly huddles and collectingupdated metrics every six weeks. RESULTS: The workgroup created a spreadsheet tool for capturingvalue data within 14 specialty CPS practices. Bi-weekly huddles wereemployed to solicit feedback, demonstrate functionality, and fosteraccountability among individual CPS to document day-to-dayinterventions. For 2010, $6.8 million in financial value wasdocumented by CPS. More than 85% of this documented value wasfrom therapy cost-avoidance (decreased cost of goods); however,approximately 14% of documented value was related to interventionsto prevent or mitigate drug-related problems. CONCLUSION: Systematic documentation of patient careinterventions within several unique clinical pharmacy practices wasassociated with meaningful financial value. Significant opportunityremains to completely document the financial impact of clinicalpharmacy interventions on overall cost of care in an integratedhealthcare delivery system. Presented at American Society of Health-System Pharmacists SummerMeeting, Denver, CO, June 12–15, 2011

Medication Safety

336. Interdisciplinary approach to medication safety:Collaborative care for developmentally disabled individuals.Philip Rolland, Pharm.D., MHA; Mexia State Supported LivingCenter, Mexia, TX Multidisciplinary Care: Collaboration and Teamwork in MedicationSafety 300 Word TI> Interdisciplinary approach to medication safety:Collaborative care for developmentally disabled individuals. AU>Philip Rolland, Pharm.D., M.H.A. Director of Clinical ProgramDevelopment, MSSLC. PURPOSE: This article describes the interdisciplinary approach tocollaborative care regarding medication safety for mentally challengedindividuals. METHODS: Our facility has a comprehensive, multifacetedinterdisciplinary and collaborative approach to medication safety. Thisprocess includes; dietary, nursing, pharmacy, psychology, psychiatryand medicine. The system utilizes suspected adverse drug eventreporting, chemical restraint clinical review, clinical communicationdocumentation, quarterly psychotropic medication review, quarterlydrug regimen review, and medication variance tracking, trending,analysis and process improvement. The QDDR is a comprehensivereview based on Texas Administrative Code Title 25 Part 1 Chapter415 Subchapter A “Prescribing Psychoactive Medications.” RESULTS: Dietary conducts monthly height, weight, BMI andnutrition analysis on each individual. Nursing performs monitoring forsigns and symptoms of side effects and adverse drug reactions byobserving first dose reactions and using both the monitoring of sideeffects scale (MOSES) and dyskinesia identification systemcondensed user scale (DISCUS) for psychopharmacologic and

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anticholinergic medications. All departments report suspected adversedrug events. Pharmacy performs ADR analysis, chemical restraintclinical review, clinical communication documentation, medicationvariance tracking, trending, analysis and process improvement,clozapine monitoring, quarterly medication use evaluation andquarterly drug regimen review for each individual. The QDDR isreviewed by medicine and psychiatry with feedback to the pharmacist.The quarterly psychotropic review is conducted by nursing andpsychiatry with input from psychology. CONCLUSION: For the past month pharmacy conducted 62quarterly drug regiment reviews, 28 suspected ADR’s, 44 clinicalinterventions, 3 chemical restraint clinical reviews, 1 MUE and 89medication variance reports and 12 clozaril reviews. Theinterdisciplinary, collaborative nature of this process provides a strongbasis for medication safety.

337E. Investigation of potential neurological effects of stabilizersused in immunoglobulin products: comparison of proline andglycine. Martin O. Spycher, Ph.D.1, Gerhard Dickneite, Ph.D.2;(1)CSL Behring AG, Switzerland; (2)CSL Behring GmbH, Marburg,Germany PURPOSE: Intravenous immunoglobulin (IVIG, 10%) solutionsformulated with glycine (GLY) are not stable for the entire shelf-lifeand/or extended times at room temperature. Proline (PRO; 250mmol/L) at pH 4.8 allows room temperature storage of IVIG (10%protein) for 3 years. To assess the neurologic safety of GLY and PRO,high-dose studies were performed in rats. METHODS: The neurobiologic state was evaluated using the Irwintest (MDS Pharma Services), which assesses autonomic andsensorimotor functions, convulsive behavior, and neurologic sideeffects of drug administration. Spatial learning and memory wereassessed using the Morris water maze task (CSL Behring; MedimodPharmacology Services). For the Irwin test, adult rats receivedintravenous infusions 7 hours daily over 5 days with either GLY orPRO, corresponding to daily doses of ≈2 and 5 g IVIG/kg bodyweight.Typical IVIG doses for antibody replacement range between 200–800mg/kg bodyweight. For the Morris water maze task, newborn ratswere injected subcutaneously with one of two dosing schemes: onesimulating autoimmune disease (days 9–13 postnatal); the other,immunodeficiency (days 9, 16, and 23 postnatal). Daily dosescorresponded to up to ≈14 g IVIG/kg bodyweight. RESULTS: PRO did not significantly affect behavior or variousneurologic parameters during or postinfusion. Rats infused with bothGLY doses showed significantly decreased spontaneous activity,increased CNS excitability, and altered autonomic measures, but nosignificant effects on neuromuscular or sensorimotor function.Cumulative doses of GLY or PRO induced statistically significantbody temperature increases after 5 days of infusion. All animals hadunimpaired learning and memory abilities; no negative effect onsearch accuracy or intensity on day 60 was observed. CONCLUSIONS: High-dose IV GLY caused some neurologic effectsin the Irwin test. PRO caused no neurologic effects of toxicologicsignificance in rats, even at doses considerably higher than routinelyused for IVIG treatment. Presented at American Academy of Allergy, Asthma, and Immunology,2007

338E. An analysis of medication errors associated with the use oftechnology. Jennifer Phillips, Pharm.D., BCPS1, BonnieBachenheimer, Pharm.D.2, Christopher Kutza, Pharm.D.2;(1)Midwestern University, Downers Grove, IL; (2)Advocate LutheranGeneral Hospital, Park Ridge, IL PURPOSE: In recent years, there have been a number ofadvancements in the area of automation and technology in thehealthcare industry. Recent literature suggests that technology maycause new types of medication-related errors. The main purpose ofthis observational retrospective study was to determine the technologymost likely to be associated with medication errors and to characterizetechnology-associated errors with regard to the type of errors made(i.e., human vs. system errors) as well as the stage of the medicationuse process and the outcome. METHODS: This was an IRB-approved retrospective, observationalstudy at a 645-bed institution. All medication errors reported from

January-December 2010 were de-identified and analyzed to determineif they were associated with the use of technology. If so, then thespecific type of technology involved was identified and the error wasfurther classified as a human error or a system error. The stage of themedication use process in which the error originated was recorded aswell as the error outcome. RESULTS: Medication errors associated with technology represented50% of the 703 errors analyzed. Computerized prescriber order entry(CPOE) was the technology most likely to be involved in medicationerrors (31%). For technology-associated medication errors, humanerrors occurred more frequently than system errors (87% vs. 13%).Technology errors were more likely to occur during the prescribing(35% vs. 16%, p<0.0001) and documentation (17% vs. 9%, p<0.001)stages of the medication use process. Technology errors were morelikely than non-technology errors to be near misses (59% vs. 51%,p<0.05). CONCLUSION: At a large institution using many forms oftechnology, CPOE represented the largest percentage of technology-associated medication errors. Technology errors were less likely toreach the patient. Future plans include a more in-depth analysis ofCPOE-related errors to identify trends and guide quality improvementinitiatives. Presented at Presented at the Illinois Council of Health-SystemPharmacists (ICHP) - Missoursi Society of Health-SystemsPharmacists (MSHP) Spring Meeting, St. Charles, MO, April 14–16,2011).

Oncology

339. Effects of standardization of urine alkalinization forhematology and oncology patients. Patricia A. Jeppson, Pharm.D.,Martha J. Glenn, M.D., Kenneth Boucher, Ph.D., J. Andrew Stuart,Pharm.D.; Huntsman Cancer Institute at the University of Utah, SaltLake City, UT PURPOSE: Though widely used in oncology protocols, the practiceof alkalinizing urine prior to high dose methotrexate therapy is notwell-documented in the literature. A urine alkalinization protocol wasdeveloped and implemented in order to 1) provide adequate hydrationwithout interruption, 2) ensure patients were receiving appropriatemonitoring, and 3) increase efficiency of compounding andadministration through the use of standardized IV fluids. The purposeof this study was to determine if standardization also decreases time totarget urine pH. METHODS: A urine alkalinization protocol was developed andimplemented in February 2009. Medical charts were reviewed for 77patients to compare outcomes prior to and after implementation of theprotocol. Outcomes measured included: time to urine pH ≥ 7, time toadministration of methotrexate, and percent of time within target urinepH interval (≥ 7 and ≤ 8). RESULTS: No differences existed between the control andintervention groups in time to urine pH ≥ 7 (5.4 hours vs. 5 hours,p=0.63) or time to administration of methotrexate (8.7 hours vs. 9hours, p=0.87). The percent of time within the target pH interval washigher for the intervention group (50.8% vs. 73.2%, p<0.005). CONCLUSIONS: A standardized urine alkalinization protocol didnot decrease time to goal pH or methotrexate administration.However, urine pH measurements were within the target pH range ahigher percentage of the time and all patients received continuoushydration throughout the course of therapy, which may result in morepredictable methotrexate clearance. Further study is needed todetermine if this intervention leads to decreased nephrotoxicity fromhigh dose methotrexate.

340. Cut down chemotherapy errors by clinical pharmacist inShanghai Cancer Center. Bo Yu, M.S., Bin Zhu, Qing Zhai, M.S.;Fudan University Shanghai Cancer Center, Shanghai, China PURPOSE: Shanghai Cancer Center, Fudan University, is one of thetop cancer centers in China. During the year of 2010, the totalnumbers of out-patient and in-patient approached 700 and 30thousand, respectively. Meanwhile, the number of patients receivingchemotherapy exceeded 100 thousand. These overwhelming forcesdrive our pharmacists executing their clinical practices mandatorilyand mightily.


METHODS: To meet these objective requirements, we combined ourprescription verification system with medical order system. With noexceptions, physicians and surgeons must send every prescription tothe verification system and wait for pharmacists review. Dutypharmacists will review the prescription according to thecorresponding medical examinations, characteristics of the drugs,incompatibilities, medication order etc. At the same time, seniorpharmacists will be sent to monitor the process of administration andrecord the adverse drug events. Furthermore, all processes involvingrecombining or admixture of cytotoxic agents, antibiotics are underthe supervision of pharmacists. RESULTS: By these above mentioned means, the prescription errorrates were cut down from around 10% to 6%. Among the remainingerrors, about 5% were medication order errors, 80% were errorsinvolving choices or volume of solvents. Traditional ChineseMedicine (TCM), which is proved to be effective in adjuvantchemotherapy, liver protection, nutrition support, etc., contributes to20–30% solvents errors. Unfortunately, around 30% of solvent errorsresult from cytotoxic agents’ prescription. CONCLUSION: Our clinical oncology pharmacists’ practices are abrand new model in China. We are seeking all kinds of assistance andcooperation to develop and improve the efficiency and effectiveness ofour clinical practices. We are also setting a national wide educationbase for clinical oncology pharmacist all over China by hostingnational wide medical continuous education and forum.

Other

341. Pharmaceutical appointment in clinical trials. SebastiãoFerreira da Silva, Pharm.D., Isabel Gomes, Pharm.D., Ana Luísa Vital,Pharm.D., Marta Nabais, Pharm.D., José Feio, Pharm.D.; Hospitaisda Universidade de Coimbra, Coimbra, Portugal PURPOSE: Clinical investigation demands the establishment ofmultidisciplinary teams. Clinical trials’ credibility and reputationdepends on the security, responsibility, transparency and tracing withwhich the clinical trial medicine and medical devices are used andconducted. Pharmaceutical appointment in clinical trials practice is apatient-centered and outcomes oriented. METHODS: A pharmacist with advanced training in clinical trialspractice and ICH-GCP guidelines is responsible to monitor pharmacyactivities. The pharmacist:- Conducts an interview and records the patient’s pharmacotherapeuticinformation. The data collected is evaluated and appropriateinformation is supplied in order to ensure adherence, safety andeffectiveness; - Assures that the patient has the correct and sufficient investigationalproduct, information and necessary knowledge to carry out the clinicaltrial plan;- Reviews, monitors and explains modifications of the therapeutic planas necessary and appropriate, in accordance with the patient andinvestigational team. RESULTS: Three pharmacists are responsible for the Clinical TrialsDepartment of the Pharmaceutical Services. During 2010, we wereinvolved in 93 clinical trials, from which 12% were phase II, 81%phase III and 4% phase IV. These clinical trials enrolled 765 patientsand were undertaken by 18 centers, with 32 sponsors and 122 differentinvestigational products. We carried out 3251 pharmaceutical visits.These pharmaceutical consultations allowed us to achieve a mediumtherapeutic adhesion rate of 98.3% with 0 drop outs. CONCLUSION: The high level of professional skills and proficiencyof an experienced pharmaceutical team proved to be of extremeimportance in the correct conductance of the clinical trial, as well as,the adherence and security of the patient to the investigational productand concomitant drugs under study. A relationship based upon caring,trust, open communication and cooperation between patient andpharmacist must be encouraged.

342. Analysis of pharmacist-driven medication reconciliationservices on hospital readmission rates, emergency room, visits,and hospital length of stay. Paula A. Helton, Pharm.D., BCPS, CGP,Susan C. Woodard, Pharm.D., BCPS, CGP; VA Tennessee ValleyHealthcare System, Nashville, TN PURPOSE: Increased length of stay and preventable rehospitalization

are persistent dilemmas that lead to escalating healthcare costs. Thisstudy assessed the effect of a pharmacist-driven medicationreconciliation service on 1) the combined endpoint of hospitalreadmissions within 30 days and ER visits within 72 hours ofdischarge and 2) hospital length of stay. METHODS: Patients were considered for inclusion in thisretrospective observational study if taking five or more medicationsprior to admission and if they were admitted for greater than 36 hours.Patients seen by a medication reconciliation clinical pharmacist uponadmission or discharge were assigned to the study group. The controlgroup consisted of patients not reviewed by a medicationreconciliation pharmacist. RESULTS: A total of 474 patients were included in the study with237 patients in the study group and 237 patients in the control group.Hospital readmissions within 30 days of hospital discharge showedstatistical significance with 31 readmissions in study group vs. 56readmissions in control group (p = 0.0042). Neither the rate of ERvisits 72 hours post discharge (11 vs. 12 visits) nor the hospital lengthof stay (4.6977 vs. 5.2738 days) was statistically significant (p=1 andp=0.2121, respectively). CONCLUSION: Our study showed that by addressing medication-related problems, pharmacist-driven medication reconciliation reduceshospital readmissions within 30 days of discharge thus providingevidence to support the importance of utilizing pharmacists to providemedication reconciliation services. Though not statistically significant,the average shortened length of hospital stay by 0.6 days may save ourinstitution an average of $1,352 to $3,808 per patient.

Pain Management/Analgesia

343. Pharmacist-led and interdisciplinary model for managementof adult cancer pain in a medical center. Yuan-Hsun Ko, B.S.1, Yu-Hsuan Yen, M.S.2, Mantzu M. Wu, Pharm.D.3, Kuei-Ju Cheng,Pharm.D.1, Hsiang-Yin Chen, M.S., Pharm.D.4; (1)Department ofPharmacy, Taipei Medical University-Wanfang Hospital, Taipei,Taiwan., Taipei, Taiwan; (2)Taipei Medical University - WanfangHospital, Taipei, Taiwan; (3)Taipei Medical University-WanfangHospital, Taipei, Taiwan; (4)Taipei Medical University-WanfangHospital., Taipei, Taiwan PURPOSE: Management principles for adult cancer pain weredeveloped and coordinated by pharmacists in a medical center inTaiwan. The aim of this study is to improve the adherence to thecancer pain guideline and analyze the opioid analgesic use. METHODS: We describe the characteristics of the population seenand notice the guide bulletin throughout the hospital. Patientdemographics were analyzed using descriptive statistics, medicationused were noted, and performance of following guide were tracked inthe before intervention (BI) group from January to June 2009 and inthe after intervention (AI) group from January to June 2010. RESULTS: A total of 160 patients included in the study. There was nosignificant difference between the two groups in the demographics.Forty-five patients (62.5%) in the AI group were fully met the guidebetter than 35 patients (40%) in the BI group (p=0.004). Thepercentage of patients used meperidine and propoxyphene decreasedby 17% through intervention. The mean of daily meperidine dosagewas dramatically decreased from 4.93 mg in the BI group to 2.45 mgin the AI group. The mean milligram of propoxyphene use per personand per day was significant decreased from 8.33 to 0.47. CONCLUSION: We are able to demonstrate that the use of apharmacist-led, interdisciplinary team produced a better compliedwith the guide and a significant decreased the usage of inappropriatemedicines for adult cancer pain.

344. An interdisciplinary approach to reducing opioid analgesicmisuse in patients with chronic noncancer pain in the primarycare setting. Michele L. Matthews, Pharm.D., CPE1, Robert N.Jamison, Ph.D.2, Edgar Ross, M.D.2, Elizabeth M. Scanlan, NP2, LoriW. Tishler, M.D.3; (1)Massachusetts College of Pharmacy and HealthSciences, Boston, MA; (2)Brigham and Women’s Hospital PainManagement Center, Chestnut Hill, MA; (3)Brigham and Women’sHospital Phyllis Jen Center for Primary Care, Boston, MA PURPOSE: Many health care professionals are reluctant to supportthe use of opioid analgesics for patients with chronic noncancer pain

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because of concerns regarding adverse effects, lack of efficacy,tolerance, and addiction. Within the past ten years the prescription ofopioids for the treatment of chronic pain has increased exponentially,primarily for noncancer pain, and the abuse of such medications isreceiving increasing notice. Chronic pain patients who show aberrantdrug-related behavior are often dismissed from a primary care practicewhen they are nonadherent with opioid therapy, instead of beingoffered interventions to reduce misuse and to improve adherence.Unfortunately, there are few treatment resources for such patients.Through the implementation of an interdisciplinary approach tochronic pain management, we are seeking to remedy that deficit, withthe goal of reducing the rate of prescription opioid misuse amongthose patients on or who are being considered for opioid therapywithin the primary care setting. METHODS: An interdisciplinary team of pain specialists consistingof a physician, clinical pharmacist, psychologist, nurse practitioner,and psychiatrist will work closely with primary care physicians toimplement the following services and programs: direct clinical supportthrough a weekly pharmacist-directed chronic pain management clinicembedded within the primary care center to provide recommendationsfor therapy and ensure adherence to an institution-wide opioid usepolicy; use of an electronic software program that conductscomputerized ‘live’ interviews of patients and offers a provider reportwith a summarized pain assessment; psychiatry consult service tomanage opioid abuse/addiction issues; and monthly providereducational sessions on pain assessment and management to promoteproper patient selection and risk assessment. RESULTS: This approach to the use of opioid analgesics will help toimprove adherence and reduce misuse within the primary care setting.


345. Examining knowledge and information seeking behaviorstowards blood transfusion among individuals with ChronicKidney Disease. Ahmad Naim, M.D.1, D. Walls, Ph.D.2, Jan Gollins,MBA3, Chuck Reynolds, M.S.4; (1)Centocor Ortho Biotech Services,LLC, Horsham, PA; (2)BDJ Solutions, LLC, Medford, MA; (3)DeltaModelling Group, Mount Prospect, IL; (4)The Benfield Group, St.Louis, MO PURPOSE: Examine knowledge and information seeking behaviorstowards blood transfusions among individuals with Chronic KidneyDisease (CKD) currently not on dialysis. METHODS: An online survey was conducted from a nationallyrepresentative patient panel in 1Q2011. Respondents were ≥18 yearsand diagnosed with CKD by a physician. Participants were askedabout blood transfusion history, information seeking behaviors, andknowledge about blood transfusion. RESULTS: Of 416 respondents, 59% (n=246) were female; 40%(n=165) were >65 years. 35% (n=144) had stage 4 and 58% (n=240)stage 3 CKD. 54% (n=226) were anemic. 43% (n=179) had receivedblood transfusion, whereas, 57% (n=237) had no transfusions. Top twosources of information were doctor (93.8%) and Internet (80.5%).Among those previously transfused, 62% received right amount ofinformation, whereas, 34.6% received too little information, and 3.4%reported receiving too much information. More than 80% oftransfused indicated they knew the reasons for and benefits of gettinga blood transfusion. Less than two-thirds received information abouteffects, risks, and time it would take, and only 26% knew the costs.Over 60% said that it is extremely important to know right blood type,screening techniques and quality of blood, and risks of infections.Among previously transfused, only half (50%) agreed that they madean informed choice about receiving blood transfusions. Among thepreviously transfused, 77% agree that they knew the benefitscompared with 49% not transfused. Similarly among previouslytransfused, 69% agreed that they knew the risks of blood transfusioncompared to 51% with no transfusion history. CONCLUSION: Doctor’s office and Internet are primary sources ofinformation about blood transfusions. Gaps in knowledge exist aboutbenefits, risks, and costs of blood transfusions. A significant numberfeel that they need more information about blood transfusion to makean informed choice. Providers should consider adopting shared-decision making with their patients.

346. Examining the patient-centered decision making attributestowards blood transfusion among individuals with ChronicKidney Disease (CKD). Ahmad Naim, M.D.1, D. Walls, Ph.D.2, JanGollins, MBA3, Chuck Reynolds, M.S.4; (1)Centocor Ortho BiotechServices, LLC, Horsham, PA; (2)BDJ Solutions, LLC, Medford, MA;(3)Delta Modelling Group, Mount Prospect, IL; (4)The BenfieldGroup, St. Louis, MO PURPOSE: Examine the patient engagement towards bloodtransfusion among individuals with Chronic Kidney Disease (CKD)currently not on dialysis. METHODS: An online survey was conducted from a nationallyrepresentative patient panel in 1Q2011. All respondents were ≥18years and diagnosed with CKD by a physician. Participants wereasked about their blood transfusion history, information seekingbehaviors, and knowledge about blood transfusion. RESULTS: Of 416 respondents, 59% (n=246) were female; 40%(n=165) were >65 years. 35% (n=144) had stage 4 and 58% (n=240)stage 3 CKD. 54% (n=226) were anemic. 43% (n=179) had receivedblood transfusion, whereas, 57% (n=237) had no transfusions. Amongpreviously transfused, only 50% indicated they shared in treatmentdecision with their doctor, whereas 40% indicated their doctor orsomeone else had made the decision for them. Among those whoindicated someone else made the decision, 82% indicated that theylike to make a shared decision. Among not transfused, only 40% areclear about their treatment choice for blood transfusion and over 75%would like to share decision to have blood transfusion with theirdoctor. Among not transfused, 30% agree that they are unsure aboutreceiving blood transfusion and less than two-thirds (60%) are likelyto stick with their decision to get a blood transfusion. About 39% ofnot transfused said it is hard to decide if benefits outweigh risks and38% said that decision is hard for them to make. CONCLUSION: There is a substantial lack of patient engagementtowards shared-decision making in blood transfusion. Individualsmost likely to receive blood transfusion expressed the mostuncertainty about their decisions and are least informed about choices,benefits, and risks. These findings suggest that a significant portion ofindividuals facing a blood transfusion feel disempowered and areinterested in engaging in shared-decision making with theirphysicians.

347. Quality of life burden in chemotherapy-naïve andchemotherapy-experienced men with metastatic prostate cancer.Mekre Senbetta, Pharm.D.1, Jamie Forlenza, Pharm.D., M.S.1, AmySmalarz, Ph.D.2, Kimberly Riggs, B.S.2; (1)Centocor Ortho BiotechServices, LLC, Horsham, PA; (2)United BioSource Corporation,Lexington, MA PURPOSE: This study evaluated the QOL burden in metastaticprostate cancer (MPC). METHODS: Eighty-four US adult men with self-reported MPCcompleted a cross-sectional survey between January-February 2011.QOL was assessed using computer-adapted versions of the FunctionalAssessment of Cancer Therapy (FACT)-General (G), –Prostate (P),and –Taxane scales and compared for respondents who self-reportedhaving had chemotherapy treatment for prostate cancer (CE group)versus those without chemotherapy (CN group). RESULTS: Average age was 63.6 years in the CN group (n=53) and64.4 in the CE group (n=31). The CN group had numerically higher(better QOL) mean FACT-G scores versus the CE group (75.9 vs.69.2, respectively, p=0.065). A statistically significant differencebetween CN and CE groups was observed for the mean physicalsubscale (21.6 vs. 18.0, respectively, p=0.003) and functional subscale(18.3 vs. 15.5, respectively, p=0.049). Compared to the CE group, theCN group reported statistically significantly higher total FACT-Pscores (106.5 vs. 96.7, p=0.049) and numerically higher FACT-PProstate Cancer Subscale (PCS) scores (30.6 vs. 27.5, p=0.069). TheCN group reported better scores within the FACT-P PCS for questionspertaining to weight (p<0.001), present comfort level (p=0.014), andability to feel like a man (p=0.015). There was no statisticallysignificant difference in total FACT-Taxane scores (128.4 CN vs.118.2 CE group, p=0.126) or FACT-Taxane subscale scores betweengroups (52.5 CN vs. 49.0 CE group, p=0.126); however, questionspertaining to numbness or tingling in the feet (p=0.019), feeling weakall over (P=0.017), and having trouble walking (p=0.004) were


statistically significant in favor of the CN group. CONCLUSION: These results suggest that certain aspects of thegeneral and disease-specific QOL for men with MPC may be better forthe chemotherapy-naive versus chemotherapy-experienced group.Given the limited sample size of both groups, further research in largepopulations of men with MPC is warranted.

348. Cost-efficacy analysis of pemetrexed in first-line treatment ofnon-small cell lung cancer. Ana Leandro, Pharm.D., ArmandoAlcobia, Pharm.D.; Hospital Garcia de Orta, Almada, Portugal PURPOSE: In a phase III trial, which included 1725 patients, andcompared to in first-line treatment of non-small cell lung cancer(NSCLC), showed similar clinical efficacy. Nevertheless, thehistology of NSCLC is known to affect the efficacy of treatments. Theobjective of this study was to evaluate the cost-efficacy of , in first-line treatment NSCLC patients, considering the different . This studywas required in order to assess treatment options in our hospital. METHODS: Based on the above-mentioned phase III trial, theefficacy of or , plus , in the first-line treatment of NSCLC wasevaluated. We considered overall survival and cancer histology.Treatment costs were calculated based on the direct cost of the drugsin 2010. This study was conducted from an institutional perspective -the hospital perspective. RESULTS: The overall survival, in years, of the NSCLC patientstreated in first-line setting is described in the table:

Histology Pemetrexed-cisplatin Gemcitabine-cisplatin1.05 0.91

cell carcinomas 0.78 0.90 large cell carcinomas 0.87 0.56 other 0.72 0.77In the associated costs calculation were considered: a body surface of1.7 m2, 5 treatment cycles and the need of granulocyte colony-stimulating factors (G-CSF), based on the frequency of described forthe two therapeutic options. For and large cells carcinomas, theincremental cost-efficacy ratios (ICER) calculated for versus were63.779€ (US$ 89.290) and 28.959€ (US$ 40.542) respectively. In thecell carcinomas and other , the option was more effective and lessexpensive. CONCLUSIONS: In the of NSCLC in which was more effective,the calculated ICER was higher for , being too elevated for it to beconsidered a cost-effective option. In cell carcinomas and other , isthe dominant option.

349. Economic impact of ambulatory clinical pharmacy services.Daniel M. Riche, Pharm.D., BCPS, CDE1, Valyncia Green, Pharm.D.2,Richard Jackson, M.D.2, Marion Wofford, M.D., M.P.H.2, CandiceAdams, A.A.2; (1)University of Mississippi School of Pharmacy,Jackson, MS; (2)University of Mississippi Medical Center, Jackson,MS PURPOSE: At the University of Mississippi Medical Center, theCardiometabolic clinic has served as a core site for ambulatoryclinical pharmacy services (CPS) for several years. Recently, a WhitePaper was published commenting on quality of ambulatory CPS. Theeconomic component of the White Paper focused on patient-perspective costs. Rarely has an institutional perspective on cost beenevaluated for ambulatory CPS. This quality assurance project isintended to ascertain if any difference in revenue exists betweenstandard of care and ambulatory CPS. METHODS: This is a retrospective review analyzing anticipatedrevenue for one physician (MD) in an insured population for onemonth. The MD covered Cardiometabolic clinic in addition to hisstandard General Medicine clinic. Charges for established patientbilling codes were evaluated. Other billing codes were ignored (e.g.,new patient, immunizations, pre-op, etc). Anticipated revenue (chargesminus write-off) and relative value units (RVU) were averaged for theMD alone and MD/Pharm.D. groups. Downstream revenue was notavailable for evaluation. A t-test was used for continuous data, and ac2 was used for dichotomous data. RESULTS: Of the patients seen by the MD, 13% were seen withPharm.D. collaboration. For one month (n=201), the MD/Pharm.D.combination significantly increased anticipated revenue by 16.4%versus an MD alone (p=0.026). The anticipated cumulative revenue

per patient seen by an MD/Pharm.D. is $97.67 versus $83.88 for MDalone. The average RVU per patient increased significantly from 1.22to 1.50 (p<0.001). Extrapolating this data for 25 patients per weekover a 40-week clinic schedule would reimburse an averagepharmacist salary of $97,670 per year when a Pharm.D. is added to astandard MD General Medicine clinic. CONCLUSION: Clinical pharmacists increased anticipated revenueand relative value when added to a physician’s General Medicineclinic. The conservatively estimated increase in annual revenue at leastjustifies partial salary reimbursement for ambulatory CPS.


350. The quest towards personalized medicine: Overview ofpharmacogenetics and safety of drug therapy. Salah M. Blaih,Ph.D., R.Ph.; Department of Chemistry and Biochemistry - Kent StateUniversity, Warren, OH PURPOSE: Single gene interactions can alter drug disposition,efficacy, safety, and tolerability. Recent studies from US hospitalssuggest that 6.7% (more than two million hospitalized patients)experience ADEs, causing approximately 100,000 deaths per year (4th

- 6th leading cause of death). CYP enzymes are responsible formetabolizing the vast majority of prescribed drugs. CYP2C9, CYP2C19, CYP2D6, as well as VKORC1, DPYD, TPMT, and UGT1A1,are polymorphic and responsible for a wide variety of ADEs. METHODS: Data, statistics, and guidelines are summarized fromvarious research articles, clinical trials, and FDA-approved druglabels. RESULTS: The pharmacokinetics and pharmacodynamics of warfarintherapy are discussed. The most common poor metabolizers(CYP2C9*2, CYP2C9 *3, and –1639G>A nucleotide substitution ofVKORC1) influence warfarin dose requirements and serve as a modelof application pharmacogenetic data: one controls the metabolism ofthe drug; the other controls the effective concentration at the site ofaction. Up to 10-fold in maintenance dose reduction is recommendedfor patients with 2C9 *2/ *3 and VKORC1 -1639 AA variants. Theeffect of the nonfunctional 2C19*2 and *3 alleles on thepharmacokinetics and antiplatelet effects of the prodrug clopidogrel ispresented. The FDA- approved drug label is to consider alternativetreatment or treatment strategies in patients identified as CYP2C19poor metabolizers. Published data indicate a marked reduction ofpharmacokinetic parameters (Cmax) of the active metabolite as wellas the antiplatelet effects, as measured by ex vivo platelet aggregationassays. Pharmacogenetic data related to cancer therapy are alsopresented. Risks of developing severe, life-threatening toxicities ofthiopurine (hematopoietic/ myelosuppression, TPMT*3A/*3Cvariants); the topoisomerase I inhibitor irinotecan (severe/fatalneutropenia, UGT1A1*28 allele); and the BCR-ABL tyrosine kinaseinhibitor Nilotinib (hyperbilirubinemia, UGT1A1*28 allele) areshown. CONCLUSION: As a result, physicians may personalize treatmentdecisions, where a reduction in the starting dose in a range of 30–90%should be considered.

Psychiatry

351. Drug-related problems with antidepressants in a hospitalsetting in India. Anantha Naik Nagappa, M.Pharm., Ph.D.1, UdayVenkat Mateti, B.Pharm., Pharm. D.2, Tarachand Lalwani, B.Pharm.,Pharm.D., P.B.2, P. V. Bhandary, M.B.B.S., M.D.,3, VerupakshaDevermane, M.B.B.S., M.D.3, Rajesh Balkrishnan, B.Pharm., M.S.,Ph.D.4; (1)Manipal College of Pharmaceutical Sciences,, Manipal,Karnataka, India, India; (2)Manipal College of PharmacueticalSciences, Manipal, India; (3)DR. A. V. Baliga Memorial Hospital,Udupi, India; (4)Center for Global Health and College of Pharmacy,Michigan, MI PURPOSE: Drug-Related Problems (DRPs) occur frequently withantidepressants leading to treatment failure and increased morbidity inthe depressed patient. The study was designed to collect preliminarydata related to antidepressant drug related problems and treatmentfailure in India. METHODS: A cross sectional observational study was carried out fora period of four months at a mental health facility in Udupi, India. All

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the prescriptions of the study population were screened for DrugRelated Problems (DRPs) such as ADRs and DDIs by using acomputerized database system. These data were assessed for thepattern of the ADRs with respect to patient demographics, nature ofthe reaction, outcome of the reactions, causality, severity andpreventability. RESULTS: A total of 120 patients were enrolled in the study and 33of them developed 50 Drug Related Problems (DRPs), in those 24Drug-Drug Interactions (DDIs) and 26 Adverse Drug Reactions(ADRs). The overall incidence of DRPs in the present study was27.5%. Among the 33 patients and the significant proportions of DRPswere in female with [p<0.01] than in male. Most of the patients whohad developed DRPs was in the age group of 36–55 yrs [p<0.01]followed by other age. The common ADRs observed werehyponatremia and headache. Considering outcomes, 20 (76.9%) ofcases recovered from ADRs and while assessing the preventability, 20(76.9%) of the ADRs were definitely preventable. When causalityassessments were conducted, we found that that majority of ADRswere probable and were found to be mild to moderately severe. CONCLUSION: An ongoing drug monitoring program aimed atassessing common drug-related problems may be key in improvingtreatment effectiveness in patients with depression. The involvementof community pharmacists in a pilot psychiatric drug monitoringprogram in India assisted in the identification of common adversedrug related problems in these patients.

RESIDENTS AND FELLOWS RESEARCH INPROGRESS

ADR/Drug Interactions

352. Comparing drug-drug interaction severity for clinicianopinion to proprietary databases. Michael J. Armahizer, Pharm.D.1,Sandra Kane-Gill, Pharm.D., M.S., FCCM2, Pamela L. Smithburger,Pharm.D., BCPS2, Amy L. Seybert, Pharm.D.2; (1)UPMCPresbyterian, Pittsburgh, PA; (2)University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: Commercial clinical decision support software (CDSS)may overestimate the severity of drug-drug interactions (DDI) becauseof their broad application; whereas, clinicians with knowledge of thepatient should be able to better assess DDI severity. The purpose ofthis project was to compare DDI severity for clinician opinion in thecontext of the patient’s clinical status to the severity of proprietarydatabases. METHODS: This was a single-center, prospective evaluation of DDIsat a large, tertiary care academic medical center between October 11,2010 and November 5, 2010 in a 10-bed cardiac intensive care unit(CCU). A pharmacist identified DDIs using two proprietary databases.The physicians (fellow and attending) and pharmacists (rounding anddistribution) caring for the patients evaluated the DDIs for severitywhile incorporating their clinical knowledge of the patient. Severitywas ranked on a scale ranging from A to D and X. RESULTS: A total of 61 patients were included in the evaluation andexperienced 769 DDIs. The most common DDIs included:aspirin/clopidogrel (n=21, 2.7%), aspirin/insulin (n=21, 2.7%) andaspirin/furosemide (n=19, 2.5%). Pharmacists ranked the DDIsidentically 73.8% of the time, compared to the physicians who agreed42.2% of the time. Pharmacists agreed with the more severeproprietary database scores for 14.8% of DDIs versus physicians at7.3%. Among the five contraindicated DDIs, two were rated ascategory B (minor severity/no action needed) and three as category C(moderate severity/monitor therapy) by the majority of the reviewers.Clinicians agreed with the proprietary database 20.6% of the timewhile clinicians ranked the DDIs lower than the database 77.3% of thetime. CONCLUSION: Proprietary DDI databases generally label DDIswith a higher severity rating as compared to clinicians who are caringfor patients. Developing a DDI knowledgebase for CDSS requirescareful consideration of the source of the severity information tocreate clinically meaningful alerts.

Adult Medicine

353. Persistent use of against label statin-fibrate combinations

from 2003 to 2009 despite FDA dose restrictions. Julie C. Alford,Pharm.D., Joseph J. Saseen, Pharm.D., Richard R. Allen, M.S., KavitaV. Nair, Ph.D.; University of Colorado, School of Pharmacy, Aurora,CO PURPOSE: Statin-fibrate combinations incur an increased risk ofmyopathy with lovastatin, rosuvastatin and simvastatin having FDAapproved maximum dose restrictions when used with gemfibrozilsince 2002. The purpose of this study was to evaluate concurrent useof HMG CoA reductase inhibitors (statins) with fibrates and assesscompliance with 2010 FDA approved dose restrictions. METHODS: This retrospective cohort study evaluated adults whowere prescribed statin-fibrate combination therapy, defined as two ormore concurrently filled prescriptions for a statin and a fibrate usingdose-based National Drug Codes between January 1, 2003 and June30, 2009. The Medstat Marketscan Claims Databases, representingover 100 employers, were used to identify patients. The primaryobjective was to describe the recent (18 month) prevalence rate ofagainst label statin-fibrate combination therapy. The secondaryobjective was to describe annual prevalence rates of against labelstatin-fibrate prescribing from 2003–2009. RESULTS: Within the 18 month period of January 2008 and June2009, 116,078 patients were prescribed concurrent statin-fibratecombination therapy of which 7.9% (n=9,155) were against labelcombinations. Simvastatin-gemfibrozil accounted for 78.2%(n=7,156) of against label combinations; moreover, 89.8% of allsimvastatin-gemfibrozil combinations (n=7,972) were against label.The annual prevalence of against label statin-fibrate combinationtherapy was 18.1% in 2003, 20.9% in 2004, 7.1% in 2005, 5.4% in2006, 6.6% in 2007, 7.6% in 2008 and 8.1% in 2009. CONCLUSION: Prescribing of against label statin-fibratecombinations occurred despite clearly established FDA dosingrestrictions. Annual prevalence rates of against label statin-fibratecombination therapy varied but were still unacceptable, and nearlyevery time simvastatin-gemfibrozil was prescribed against label. Theupdated 2011 FDA labeling expands dose restrictions for simvastatinto include additional maximum dose restrictions and a newcontraindication with gemfibrozil. Based on our data, proactiveapproaches to ensure compliance with FDA labeling that promotepatient safety are needed.

Ambulatory Care

354. The role of clinical pharmacist in a HIV care team: aretrospective review. Cathy Hau, Pharm.D., Kirsten Balano,Pharm.D., AAHIVE; University of California, San Francisco, SanFrancisco, CA PURPOSE: The purpose of this study is to establish referral criteriafor a clinical pharmacy adherence services in the HIV Clinic at theSonoma County in California by 1) describing the clinicalinterventions and patient population that are being served bypharmacists in the HIV clinic, and 2) identifying a subpopulation ofHIV patients whom pharmacists’ intervention will be the mostbeneficial for their disease state management. METHODS: The study is conducted as a non randomized,retrospective database review that utilizes the Sonoma County HIVpatient database to compare baseline demographic data for HIVpatients with or without pharmacists’ follow up. This clinical databasecontains demographic and clinical information of about 500 patientsand is being maintained by physicians in order to monitor patient care.In addition, medication lists and clinical pharmacy interventions areincluded in the database. Using data from January 2009 to December2010, we compared clinical characteristics between patients whoreceived pharmacists’ care and those who did not. We evaluated thetypes of pharmacist interventions provided. Ultimately, we plan togenerate a set of clinical parameters that warrant pharmacists’interventions. RESULTS: Preliminary results suggest patients who were referred topharmacist’s care because they have history of antiretroviral resistanceand have a more complex antiretroviral regimen. Pharmacy serviceswere delivered as clinic visits and telephone follow-up at equalportion. Few categories of clinical interventions may not require theexpertise of an HIV-trained pharmacist.CONCLUSION: Preliminary results from this database review reveal


patient factors that allow pharmacist to create referral system forpharmacist adherence services. We identified the spectrum ofpharmacist services and how these services were delivered. Criteriafor referral to pharmacist’s care will be established pendingcompletion of database review.

Cardiovascular

355. Simvastatin amiodarone drug interaction alert: adherence todosing recommendations before and after the implementation of anew computerized drug-drug interaction alert. Rathasen Prom,Pharm.D.1, Craig Umscheid, M.D.2, Sarah A. Spinler, Pharm.D.,FCCP, BCPS1; (1)University of the Sciences in Philadelphia,Philadelphia, PA; (2)University of Pennsylvania, Philadelphia, PA PURPOSE: In patients receiving amiodarone, the FDA previouslyrecommended that daily dose not exceed 20 mg. In June 2011, thepackage labeling was revised with a new recommended dose of 10mg daily when co-prescribed with amiodarone. The purpose of thisstudy was to compare the frequency of appropriate prescribing beforeand after a revised computerized physician order entry (CPOE) alert ata large academic medical center. METHODS: Medical records of consecutive patients who wereadmitted to a 60-bed cardiology service for a two-month time periodwill be reviewed and the frequency of appropriate orders in patientsprescribed amiodarone will be compared to a two-month baselineperiod prior to the implementation of the revised CPOE alert. Theprimary end point is the percentage of completed orders which areappropriate. A completed order is defined as an order which wasprocessed after the receipt of the drug interaction alert. An appropriateorder is defined as an order for ≤ 20 mg/day or ≤ 10 mg/day for theold or new alert, respectively, or for an alternative non-interacting .Key secondary end points include the percentage of completed ordersfor > 20 mg/day (old alert) or > 10 mg/day (new alert) which werechanged to ≤ 20 mg/day (old alert) or ≤ 10 mg/day (new alert) or anon-interacting . RESULTS: In the control group (old alert), 56% (9/16) of completedorders were appropriate. Among the 44% (7/16) of inappropriateorders, 43% (3/7) were subsequently changed to an appropriate orderduring hospitalization. In the analysis which included all , 86%(37/43) of completed orders were appropriate. Data collection for thenew alert is ongoing. CONCLUSION: It is anticipated that the new alert will result indecreased inappropriate orders when co-prescribed with amiodarone.

356. Evaluation of bleeding risk using HAS-BLED scoring inpatients with atrial fibrillation receiving enoxaparin bridgingtherapy. Julia M. Underwood, Pharm.D.1, Kelly C. Rogers,Pharm.D.2, Maria Pham, Pharm.D.1, Robert Parker, Pharm.D.2,Shannon W. Finks, Pharm.D.2; (1)Veterans Affairs Medical CenterMemphis, Memphis, TN; (2)University of Tennessee College ofPharmacy, Memphis, TN PURPOSE: In patients with atrial fibrillation, bridging treatment withlow molecular weight heparins (LMWH) or unfractionated heparin isfrequently used to reduce stroke risk during periods of subtherapeuticwarfarin anticoagulation. The risk of bleeding from bridging therapyremains unclear, creating difficulty in balancing the risks and benefitsof bridging therapy. The HAS-BLED criteria were developed to assessthe risk for major bleeding in patients with atrial fibrillation treatedwith antithrombotic therapy. However, HAS-BLED criteria have notbeen evaluated in patients undergoing bridging therapy. The purposeof this study was to assess the utility of the HAS-BLED criteria inpatients with atrial fibrillation being bridged with enoxaparin. METHODS: A retrospective chart review was conducted of patientswith atrial fibrillation receiving concomitant warfarin and enoxaparintreatment from July 1, 2007 to December 31, 2010. The followinginformation was collected for each enoxaparin bridging episode:demographic data, warfarin and enoxaparin dosage, and CHADS2 andHAS-BLED scores. Bleeding episodes were classified according toTIMI and GUSTO criteria. RESULTS: A total of 118 patients meeting inclusion criteria havebeen reviewed thus far. A total of 16 patients (13.6%) experienced aclinically significant bleeding episode (TIMI major/minor or GUSTOsevere/moderate). A trend toward increased bleeding (p=0.08) was

present when a patient’s HAS-BLED score exceed the CHADS2 score.Of the 16 patients that bled, 6 (37.5%) had a HAS-BLED score greaterthan the CHADS2 score. Of the 102 patients without bleeding, 17(16.7%) had a HAS-BLED score greater than the CHADS2 score. CONCLUSIONS: Patients with atrial fibrillation receivingenoxaparin bridging are at risk of clinically significant bleeding. TheHAS-BLED scoring system may be useful to predict bleeding risk inthis cohort of patients. Analysis of additional patients is ongoing.

Critical Care

357. Incidence of hyperglycemia in at risk medical intensive careunit patients upon cessation of intravenous insulin infusions. ErinN. Frazee, Pharm.D.1, Joanna L. Stollings, Pharm.D.2, Heather A.Personett, Pharm.D.1, Garrett E. Schramm, Pharm.D.3, Philip J. Kuper,Pharm.D.4; (1)Mayo Clinic, Rochester, MN; (2)Mayo ClinicRochester, Rochester, MN; (3)Mayo Clinic, Rochester, Rochester,MN; (4)Mayo Clinic Rochester - Mayo Foundation, Rochester MN,Rochester, MN PURPOSE: To describe the incidence of hyperglycemia (≥ 180mg/dL) upon cessation of continuous intravenous (IV) insulininfusions in at risk medical intensive care unit (MICU) patients METHODS: This study was a retrospective review of 95 adult MICUpatients at Mayo Clinic in Rochester, Minnesota. Included patientsreceived ≥ 8 hours of a continuous IV insulin infusion per an existingprotocol. Excluded patients expired during therapy, received insulinfor a toxicologic emergency or did not consent for research. Datacollected pertained to demographics, medications, nutrition, and bloodglucose (BG) concentrations in the 24 hours following discontinuationof the infusion. Patients were analyzed in a-priori defined subgroupsbased on hyperglycemic risk including corticosteroids/diabetes(N=20), no corticosteroids/diabetes (N=42), corticosteroids/nodiabetes (N=21), or neither risk factor (N=12). RESULTS: Ninety-five patients were included, with a median numberof five (range 3–24) available BG measurements. The primaryendpoint of any episode of hyperglycemia within 24 hours of infusiondiscontinuation occurred in 63% of patients, of which 41% had ≥ 50%of reported BG ≥ 180 mg/dL. The hyperglycemia incidence among thesubgroups was significantly different (steroids/diabetes 85%, nosteroids/diabetes 76%, steroids/no diabetes 38%, neither risk factor25%; p=0.0001). Transition insulin, defined as subcutaneous insulin oran insulin pump initiated prior to infusion discontinuation, wasadministered to 44 (46%) patients, most commonly to patients withboth risk factors (60%) and isolated diabetes (60%). SubcutaneousNPH or glargine were selected in 80% of cases, but transitionstrategies were heterogeneous. CONCLUSION: The incidence of hyperglycemia in MICU patientsis common, particularly in those with diabetes and ongoing steroidtherapy. Upon discontinuation of IV insulin infusions, transitioninsulin is administered inconsistently. Routine implementation ofinsulin transition strategies in the highest risk patients is needed toreduce the incidence of post-infusion hyperglycemia.

358. Blood pressure control in the hospitalized elderly traumapopulation. Lina Saliba, Pharm.D., Anthony T. Gerlach, Pharm.D.,BCPS, FCCM; The Ohio State University Medical Center, Columbus,OH PURPOSE: It is well known that chronic hypertension leads to long-term complications, but there are no studies to date that directlyexamine the effects of inpatient hypertensive episodes in the traumapopulation. The purpose of this study is to determine whether in-hospital episodes of hypertension in trauma patients lead to increasedmorbidity including end-organ damage. METHODS: A retrospective review of trauma patients 45–89 yearswho presented to The Ohio State University Medical Center betweenJanuary 2008 and September 2008 was completed. Patients wereclassified based on whether or not they experienced in-hospitalhypertension and were assessed for complications using written andelectronic medical records. Hypertension was defined as any readingof systolic blood pressure (SBP) ≥ 180 and/or diastolic blood pressure(DBP) ≥ 110 mmHg or at least two readings of SBP ≥ 160 and/or DBP≥ 100 mmHg. The primary outcome was a composite of myocardialinfarction, stroke, venous thromboembolism, and acute kidney injury.

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Statistical analysis was performed by Fisher’s exact for nominal data,Mann-Whitney U for non-parametric data, and t-test for parametricdata. RESULTS: One-hundred seven patient charts were reviewed and 43(40%) of patients developed at least one hypertensive episode duringhospitalization. A total of 9 (8.4%) patients developed the primaryoutcome, 6 (14%) in the hypertensive group compared to 3 (4.7%) inthe non-hypertensive group, p=0.15. More patients that developedhypertension required an ICU admission compared to the non-hypertensive patients (16 (37.2%) vs. 9 (14.1%), p=0.01). Of the fivehypertensive patients that met the primary endpoint and were on homeantihypertensive medications, two were not restarted on any homemedications initially, two were restarted on some, and one wasrestarted on all. CONCLUSION: Hypertensive episodes occurred in 43 (40%)patients. There was a trend for more complications in the hypertensivearm; however, further research is needed.

359. Evaluation of a standardized magnesium sulfate infusionprotocol in aneurysmal subarachnoid hemorrhage. A. RebeccaBickley, Pharm.D., Sarah A. Young, Pharm.D., Edward C. Seidl,Pharm.D., Daniel A. Shade, M.D.; Allegheny General Hospital,Pittsburgh, PA PURPOSE: This study evaluated a standardized magnesium sulfate(MgSO4) infusion protocol for maintaining targeted magnesium serumconcentrations [2.4–3 mg/dL] in patients with vasospasm versuspatients without vasospasm secondary to aneurysmal subarachnoidhemorrhage (aSAH). METHODS: Patients admitted with aSAH from 2008 to 2009 thatreceived a standardized MgSO4 protocol for at least 24 hours with 3serum magnesium levels were included in this single-centeredretrospective cohort study. The primary endpoint was to compare thepercentage of levels within the targeted serum magnesiumconcentration for the duration of therapy in patients who developedvasospasm versus patients with no vasospasm. Secondary endpointswere to compare the magnesium concentration and the percentage oftime within the targeted range in patients who experienced vasospasmversus no vasospasm. In addition, the percentage of time on themagnesium infusion and the serum magnesium concentrations 24hours prior to vasospasm and the occurrence of adverse effects wereevaluated. RESULTS: Data on 59 patients demonstrated no difference inpercentage of magnesium levels (62.8% vs 62.0%) or time within thetargeted range (62.9% vs 65.3%) for the vasospasm versus non-vasospasm groups respectively. Incidence of hypotension was higherfor the non-vasospasm group (21.9% vs 14.8%). The mean time on theinfusion 24 hr prior to vasospasm was 21.9±3.8 hours. In patients witha mean serum magnesium level greater than 3 mg/dl, 6.3%experienced vasospasm while 14.4% did not. CONCLUSION: The standardized MgSO4 protocol demonstrated nodifference in percentage of levels or time within the targetedconcentrations between the vasospasm and non-vasospasm groups.The utility of MgSO4 infusion protocols in aSAH needs to be furtherevaluated.

Education/Training

360. Teaching emphasis within pharmacy residency programs.Ibrahim Sales, Pharm.D.1, Susan Meyer, Ph.D.2, Sandra Kane-Gill,Pharm.D., M.S., FCCM2, Denise Howrie Schiff, Pharm.D.2;(1)University of Pittsburgh Medical Center, Pittsburgh, PA;(2)University of Pittsburgh School of Pharmacy, Pittsburgh, PA PURPOSE: American Society of Health System Pharmacy (ASHP)standards for required teaching experiences do not provide guidanceon implementation. Identified components of residency teachingprograms are: 1) structured seminars on teaching; 2) practical teachingexperiences; 3) teaching portfolio development; and 4) teachingmentorship. The purpose of this study is to determine whether thesefour components contribute to the development of residents’confidence in teaching. METHODS: A 54-question survey was designed. An email was sentto the directors of all ASHP-accredited Pharmacy Practice residencies(n=546) requesting the survey link to be forwarded to the 2009 – 2010

residents (n=667). The four components were assessed for thelikelihood of an association with the resident’s perception of his or herconfidence for teaching abilities using a univariate logistic regressionanalysis. RESULTS: A 41% (276/667) response rate was obtained representing23% of Pharmacy Practice programs. Residents who participated instructured seminars on teaching were more confident in developinginstructional objectives (OR 5.69; 95% CI 1.50–21.58), assessingclassroom learning (OR 3.77; 95% CI 1.48–9.60), and classroommanagement (OR 3.19; 95% CI 1.09–9.30). Participants in practicalteaching experiences were more confident in their presentation skills(OR 6.86; 95% CI 1.36–34.58), implementing active learningstrategies (OR 3.44; 95% CI 1.02–11.66), assessing classroomlearning (OR 3.72; 95% CI 1.44–9.60), and precepting APPE students(OR 16.00; 95% CI 2.70–94.68). Residents who compiled teachingportfolios were more confident in developing statements of teachingphilosophy (OR 10.73; 95% CI 4.36–26.40). Residents were moreconfident classroom management (OR 3.78; 95% CI 1.52–9.40) ifthey had a teaching mentor. CONCLUSION: Structured seminars on teaching and practicalteaching experiences are important components of teaching programsfor pharmacy residents to enhance valuable skills and confidence.

361. Enhancing physician awareness of out-of-pocket medicationcosts to improve patient care. Sheryl B. Fleisch, M.D., Ted J. Turner,Pharm.D., Jamie Montgomery, R.Ph., BCPP, Michelle L. Gross,Pharm.D., Tanya Fabian, Pharm.D., Ph.D., BCPP; Western PsychiatricInstitute and Clinic, University of Pittsburgh Medical Center,Pittsburgh, PA PURPOSE: Many patients discharged from psychiatric hospitals areunable to afford their psychotropic medications, resulting inmedication non-adherence and subsequent relapse. The purpose of thisstudy is to assess knowledge of out-of-pocket medication costs andattitudes toward cost effective prescribing practices among psychiatryresidents at Western Psychiatric Institute and Clinic (WPIC). METHODS: An anonymous online survey was disseminated toWPIC residents via email. Non-responders were emailed up to twoadditional times. Survey items included demographics and questionsrelated to medication costs and prescribing practices. RESULTS: A total of 67 of 78 residents (86%) completed the onlinesurvey. Out of a 5-point Likert scale, residents ranked the followingcategories highest: believing cost influences whether patients fillprescriptions (4.64), believing physicians should be knowledgeableabout the cost of medications they are prescribing (4.48), and feelingcomfortable with medications available on the $4 generic program(4.33). Residents ranked the following categories lowest: accessingdrug cost information prior to writing a prescription (2.93), awarenessof manufacturer-sponsored patient assistance programs (2.88) andawareness of patient copayment amounts when prescribingmedications (2.78). Knowledge of specific psychotropic medicationswas also limited. CONCLUSION: Resident physicians recognize the importance ofbeing knowledgeable about the cost of medications and understand theimpact of cost on prescription filling. However, they do not routinelyaccess drug cost information for the prescriptions they write nor dothey understand all factors that influence cost of prescriptions forpatients. Increasing resident physician awareness of out-of-pocketpsychotropic medication costs prior to prescribing may improveprescribing practices at WPIC and thus result in decreased out-of-pocket costs to patients. This may ultimately increase medicationaccess and promote medication adherence.

362. Prevalence of board certification among pharmacy practicefaculty at US schools/colleges of pharmacy. Kimberly A. Toussaint,Pharm.D.1, Kristin Watson, Pharm.D., BCPS2, Joel C. Marrs,Pharm.D., BCPS3, Deborah A. Sturpe, Pharm.D., BCPS2, Sarah L.Anderson, Pharm.D., BCPS3, Stuart T. Haines, Pharm.D., BCPS2;(1)University of Maryland Medical Center, Baltimore, MD;(2)University of Maryland School of Pharmacy, Baltimore, MD;(3)University of Colorado School of Pharmacy, Aurora, CO PURPOSE: Accreditation Council for Pharmacy Education Standardsstate that pharmacy practice faculty should have or be workingtowards credentials related to their area of practice/expertise,


including certification through the Board of Pharmacy Specialties(BPS). This study was conducted to determine the prevalence of boardcertification among pharmacy practice faculty at US schools/collegesof pharmacy. METHODS: The primary objective was to determine the prevalenceof board certification among pharmacy practice faculty at USschools/colleges of pharmacy. The secondary objectives were todetermine the prevalence of board certification by faculty rank,geographic region, and in public compared to private pharmacyschools. A list of current board certified pharmacists was obtainedfrom BPS. This list was compared to the American Association ofColleges of Pharmacy (AACP) online database of pharmacy practicefaculty to create a list of currently board certified pharmacy practicefaculty in the US. RESULTS: The overall prevalence of board certification amongpharmacy practice faculty at US schools/colleges of pharmacy is 37%(1063/2867). Assistant professors are slightly more likely to be boardcertified (39.4%) than either associate professors (38.8%; p=0.067) orfull professors (30.3%; p<0.01). Instructors are the least likely to beboard certified (6.2%; p<0.001). Board certification varied significantby region (p<0.05). Region 2 (schools in New Jersey, Pennsylvania,Maryland, Virginia, and West Virginia) has the highest prevalence ofboard certified pharmacy faculty (45.4%) and region 7 (schools inIdaho, Montana, Oregon, Utah, and Washington) has the lowestpercentage (29.3%; p<0.01). Private and public pharmacy schoolswere found to have similar rates of board certification (36.8% vs.37.6%, p=0.684). CONCLUSION: The prevalence of board certification amongpharmacy practice faculty at US schools/colleges of pharmacy isrelatively low. The highest prevalence was found among assistantprofessors and the eastern regions.

363. Assessing the impact of an introductory biopharmaceuticalindustry elective on student rotation preferences and careerchoices. Samantha R. Llanos, Pharm.D., Kelsey White, Pharm.D.,Eleanor Yu, Pharm.D., Fae Wooding, Pharm.D.; MassachusettsCollege of Pharmacy and Health Sciences, Worcester, MA PURPOSE: New developments in biotechnology have promptedmany colleges of pharmacy to include biotechnology lectures andcourses into their curriculum. The Introduction to BiopharmaceuticalIndustry elective is offered in an accelerated Doctor of PharmacyProgram to provide students with an overview of career opportunitiesfor pharmacists in the industry. The purpose of this study is to assessstudent knowledge of opportunities within the biopharmaceuticalindustry and the impact of this elective on future experiential rotationpreferences and career choices. METHODS: A 12-item survey was created and administered topharmacy students in their first professional year prior to thebeginning of the Introduction to Biopharmaceutical Industry elective.Students responded to queries regarding demographics andperceptions of the science, business, and role of the pharmacist withinthe biopharmaceutical industry. Students will respond to a similarsurvey at the completion of the course to reassess their knowledge andevaluate the impact of the elective on their rotation preferences andcareer choices. RESULTS: Final results are pending. A total of 16 students completedthe initial survey. Preliminary results indicate that 9 students (56%)did not have any experience working in the biopharmaceuticalindustry. Students were most familiar with the areas of clinicalresearch and drug safety within biopharmaceutical industry, 6 students(38%) and 4 students (25%), respectively. Students were undecided asto whether they would pursue a rotation (44%), fellowship (38%), orcareer (44%) within the biopharmaceutical industry. CONCLUSION: Preliminary results suggest that many students arenot aware of career opportunities in the biopharmaceutical industry.Ongoing data collection and analyses will provide more definitiveconclusions regarding the impact of this elective.

Family Medicine

364. Use of an adherence estimator and individualized counselingfor new chronic medication prescriptions. Robert S. Helmer,Pharm.D.1, Sarah A. Treadway, Pharm.D.1, Michelle Z. Farland,

Pharm.D., BCPS2, Shaunta’ M. Ray, Pharm.D., BCPS2; (1)Universityof Tennessee College of Pharmacy/University of Tennessee MedicalCenter, Knoxville, TN; (2)University of Tennessee College ofPharmacy, Knoxville, TN PURPOSE: Medication non-adherence has and continues to be achallenge for healthcare providers. The primary objective of this studyis to assess the impact of individualized pharmacist counseling using asurvey to predict the rate of initial fill of new chronic medicationsfollowing hospitalization. METHODS: This prospective study enrolled adult patients,discharged from an inpatient family medicine teaching servicefollowing receipt of a prescription for a new chronic medication.Patients were asked to complete the Adherence Estimator® (Merck &Co. Inc.) survey for each new medication prescribed. This validated,3-item survey consists of statements that assess patient concernsregarding medication indication, adverse events, and cost. Patientresponses were scored and stratified into low, medium and high riskfor primary non-adherence. Pharmacists provided individualizedcounseling to patients based on survey results. Follow-up occurred 1-week after the initial encounter. The dispensing pharmacy wascontacted to ascertain initial fill date, product dispensed, quantity, andpatient payment. The primary outcome of the study was rate of initialprescription fill. RESULTS: To date 20 patients with 31 medications have beenenrolled. Over half of the medications prescribed were lipid-loweringagents or diuretics. Overall 77% of the current patients filled theirprescription within one week. Based on Adherence Estimator®(Merck & Co. Inc.) score, 29% of patients were categorized as highrisk for non-adherence, 29% medium risk and 42% low risk. Oneweek fill rates for high, medium, and low risk groups were 100%,77%, and 62%, respectively. CONCLUSION: Enrollment is ongoing. One observed limitation isthe literacy level of the survey tool is above that of our patientpopulation. Preliminary results suggest focused, individualized patientcounseling may have contributed to the increased primary adherencerate in the high risk group. However, final conclusions cannot be madeuntil the predetermined study population has been enrolled.

365. Evaluation of an electronic health record warfarindocumentation system within a family medicine residencyprogram. Nicole D’Antonio, Pharm.D., Roberta Farrah, Pharm.D.,BCPS; UPMC St. Margaret Hospital, Pittsburgh, PA PURPOSE: Use of a warfarin documentation system in an electronichealth record (EHR) is valuable to managing warfarin patients andalso serves as a teaching tool for family medicine residents. Inpractice, accurate electronic warfarin documentation is a challengedue to issues such as multiple users, irregular use, limited training, andmany data entry points. Consequently, necessary information thatguides anticoagulation decision-making can be absent, misinterpreted,or contradictory to office visit notes. This two-year research projectaims to analyze the accuracy of an existing and alternative electronicwarfarin documentation system and to determine a workflow thatworks best for our outpatient facilities. METHODS: Pre- and post-surveys will be distributed to physicians,nurses, and pharmacists in order to evaluate provider perspectivesabout documenting anticoagulation information. A retrospective chartreview will be performed on patients receiving warfarin therapy,comparing the accuracy of an existing and alternative warfarinflowsheet to office visit notes or telephone notes. RESULTS: Pre-survey results show that 43.6% of providers wereuncomfortable with the initial warfarin documentation system. Chartreview of existing and alternative documentation workflows and post-survey will be completed by Fall 2011. Accuracy rates for flowsheetsat the office visit level and the patient level will be calculated for theinitial and alternative workflows. Common reasons for inaccuracy,provider comfort, and perception of time and difficulty involved withdocumentation will also be collected. CONCLUSION: The results of this study are anticipated to developa practice-specific workflow in order to improve accurate warfarindocumentation and effective warfarin management.

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Geriatrics

366. The use of valproic acid or oxcarbazepine to treat dementia-related agitation. Rachel L. Freytag, Pharm.D., Jessica K. Cather,Pharm.D., BCPS, Susan M. Fosnight, R.Ph., CGP, BCPS, Dorcas J.Letting, Pharm.D., BCPS; Summa Health System, Akron, OH Antipsychotic medications (AP) are used off-label for the treatment ofdementia-related agitation (DRA). AP hold a black box warningstating that using AP for dementia-related psychosis can increasemortality in a dose related fashion. The use of valproic acid (VPA) andoxcarbazepine (OX) to treat these patients has increased since theblack box warning was released; however, the efficacy and safety ofthese medications is uncertain. PURPOSE: Determine the efficacy and safety of VPA or OX for thetreatment of DRA. METHODS: This retrospective case-matched chart review evaluatesthe use of VPA and OX use in DRA patients admitted to St. ThomasHospital’s geropsychiatric inpatient unit. Cases are patients started onVPA or OX to treat DRA and controls are patients treated with ascheduled AP. Twenty-nine cases matched with controls were found;twenty VPA and nine OX patients. The primary outcome measure isthe average amount of AP per day (in haloperidol equivalents) used totreat DRA. Secondary outcomes include length of stay, readmissionwithin 30 days, continuation of VPA or OX upon discharge, as well asthe occurrence of hyponatremia, hyperammonemia, andthrombocytopenia. RESULTS: The average daily dose of VPA and OX were 287 mg and310 mg respectively. Baseline characteristics were similar between allgroups. No outcomes were statistically significant; however, therewere trends towards significance. The average daily haloperidolequivalent dose trended down for all cases vs. all controls (1.50mg/day vs. 1.85 mg/day). VPA cases vs. VPA controls (1.64 mg/dayvs. 1.92 mg/day) and OX cases vs. OX controls (1.23 mg/day vs. 1.72mg/day) also trended towards a decrease in the amount of AP useddaily. CONCLUSION: Neither VPA nor OX were shown to significantlydecrease the amount of AP used in patients treated for DRA, however,both VPA and OX had a trend towards decreasing the amount of APused.

367. The effect of haloperidol loading dose on the duration ofdelirium. Melinda D. Garner, Pharm.D.1, Susuan M. Fosnight, R.Ph.,CGO, BCPS1, Dorcas Letting-Mangira, Pharm.D.1, Elizabeth E.Baum, M.D.1, Rex D. Wilford, D.O., R.Ph.1, Kyle A. Allen, D.O.1,Susan Hazelett, RN1, Lyn Benedict, RN1, Michael Hewit, M.S.2;(1)Summa Health System, Akron, OH; (2)Northeastern OhioUniversities Colleges of Medicine and Pharmacy, Rootstown, OH PURPOSE: Delirium is a common condition in hospitalized elderlypatients that has been associated with poor outcomes including longerlength of stay, increased nursing facility admissions, and increasedmortality. There is little evidence based information to guide thepharmacological treatment of delirium. Haloperidol has become goldstandard of treatment, although dosing guidelines are not currentlyavailable. Experts recommend a haloperidol loading dose, howeverthere is no evidence based literature to support this dosing ofhaloperidol. The aim of this study is to compare efficacy and safety ofdelirium medication regimens in elderly patients that received ahaloperidol loading dose versus those that did not received ahaloperidol loading dose. METHODS: This is a matched, case-control, retrospective chartreview evaluating delirium treatment with and without a haloperidolloading dose in elderly patients. The primary endpoint was the time, inhours, from the initial medication administration until two consecutivenegative delirium scores were recorded or until the patient wasdischarged. The length of stay, discharge disposition, deaths beforedischarge, and QTc prolongation were collected and are the secondaryoutcomes. RESULTS: Data from twenty-one case-control matched pairs wascollected. There was no statistically significant difference in theprimary outcome between the cases and controls. CONCLUSION: Patients who cleared delirium before discharge hada trend towards a shorter length of stay and also decreased duration ofdelirium if the haloperidol loading dose was administered. Patients

who had a shorter duration of delirium were significantly more likelyto be discharged to home (p=0.0006).


368. Comparison of aPTT vs. anti-Xa assay for the therapeuticmonitoring of unfractionated heparin. Darko Todorov, Pharm.D.,Michael Cunningham, Pharm.D., Suzanne Conyne-Rapin, Pharm.D.;UC Health-University Hospital, Cincinnati, OH PURPOSE: The primary goal of the study was to compare time totherapeutic activated partial thromboplastin (aPTT) or antifactor-Xa(anti-Xa) assay for patients receiving therapeutic unfractionatedheparin (UFH). The study evaluated the performance improvementinitiative involving conversion from aPTT to anti-Xa assay for thetherapeutic monitoring of UFH within our hospital. METHODS: This retrospective, chart review study included patientstreated according to the hospital’s standard UFH protocol for deepvenous thrombosis (DVT) and/or pulmonary embolism (PE).Outcomes measured included the percentage of patients withtherapeutic aPTT or anti-Xa values at 6, 12, 24, 48 and 72 hours afterUFH initiation, percentage of with adverse effects requiring UFHdiscontinuation, and evaluation of the cost associated with each assay. RESULTS: Of the 509 patients screened, 152 were included in theaPTT (n=76) or anti-Xa group (n=76). There was no statisticaldifference between aPTT (61.8%) and anti-Xa (77.6%) groups(p=0.052) in percentage of cumulative patients achieving therapeuticvalues at 24 hours. There was no significant difference in number ofadverse events, including bleeding, that led to discontinuation of UFH.Significantly fewer anti-Xa assays were performed as compared toaPTT assays (mean 4.2 vs. 6 tests respectively) to reach therapeuticlevels with UFH, however it did not lead to significant laboratory costsavings. CONCLUSION: There was no significant difference in thecumulative number of patients achieving therapeutic aPTT or anti-Xalevels at 24 hours. While fewer tests were performed in the anti-Xagroup, it was not associated with laboratory cost savings due to thecost difference at baseline. A larger study is needed to assess outcomedifferences between aPTT and anti-Xa when used for monitoring oftherapeutic UFH.

369. Evaluation of compliance to American College of ChestPhysicians guidelines for warfarin reversal with vitamin K.Giavanna M. Russo-Alvarez, Pharm.D.1, Stacey Miske, Pharm.D.2,Leslie Gingo, Pharm.D.1; (1)University of Pittsburgh Medical CenterSt. Margaret, Pittsburgh, PA; (2)University of Pittsburgh MedicalCenter Northwest, Seneca, PA PURPOSE: The study documented vitamin K therapy received bypatients taking warfarin in order to 1) assess physician compliancewith the 2008 American College of Chest Physician (ACCP)guidelines for excessive anticoagulation, 2) assess reasons fornoncompliance, and 3) quantify the incidence of thromboembolismand major and minor bleeding after vitamin K administration and 30days post-discharge; warfarin overcorrection; and warfarin resistance. METHODS: Electronic medical records of 117 inpatients admittedfrom January 1, 2010 to September 30, 2010 at a community teachinghospital were reviewed. Patients were included if greater than 18 yearsand were receiving both warfarin and vitamin K. Patients wereexcluded if vitamin K was used for reversal of the internationalnormalized ratio (INR) prior to surgery or invasive procedures; or forreasons other than to reverse the anticoagulant effect of warfarin. RESULTS: Physician compliance to the 2008 ACCP guidelines was27.4%. The top three reasons for noncompliance includedadministering vitamin K when the INR was < 5.0 and no significantbleeding (29%); subcutaneous administration of vitamin K (20%); andintravenous administration of vitamin K when oral routerecommended (12%). Three patients were readmitted within 30 dayspost-discharge with major bleeding while zero patients werereadmitted with a thromboembolism or minor bleeding. Of the 117patient charts reviewed, 35% experienced warfarin overcorrection and7% developed warfarin resistance. CONCLUSIONS: Despite wide acceptance of the 2008 ACCPguidelines, physician compliance is still suboptimal. Academicdetailing involving face-to-face educational sessions with physicians


or the development of a computerized physician order entry (CPOE)decision support order set may increase compliance at institutions. Theclinical significance of noncompliance with the 2008 ACCP guidelinesfor vitamin K administrations warrants further study.

Infectious Diseases

370. Vancomycin serum levels and efficacy in methicillin resistantStaphylococcus aureus (MRSA) infections. Khusbu Patel, Pharm.D.,William Kernan, Pharm.D., BCPS; Cleveland Clinic Florida, Weston,FL PURPOSE: The rationale of therapeutic drug monitoring is toimprove clinical outcomes and minimize toxicity. Serum vancomycintrough levels are measured routinely to maximize outcomes oftherapy. The objective of this study is to determine a correlationbetween vancomycin serum levels and efficacy in patients withMRSA infections. METHODS: This is a retrospective, single-center, observationalstudy conducted at CCF, a 150-bed community teaching hospital. Thestudy includes all hospitalized patients from September 2009 toSeptember 2010 with positive MRSA cultures that have beenmaintained on vancomycin for three or more days. Patient data wascollected from their electronic medical records. Patients with positiveoutcomes will be compared to those with negative outcomes and acorrelation with vancomycin serum levels will be determined. RESULTS: CONCLUSION:

371. Review of anidulafungin utilization in patients with hepaticdysfunction at a large academic medical center. Heather A.Personett, Pharm.D.1, Erin N. Frazee, Pharm.D.1, Garrett E. Schramm,Pharm.D.2, Joanna L. Stollings, Pharm.D.3, Philip J. Kuper, Pharm.D.4;(1)Mayo Clinic, Rochester, MN; (2)Mayo Clinic, Rochester,Rochester, MN; (3)Mayo Clinic Rochester, Rochester, MN; (4)MayoClinic Rochester - Mayo Foundation, Rochester MN, Rochester, MN PURPOSE: To illustrate prescribing patterns of anidulafungin whenrestricted to use as an alternative to caspofungin in patients withmoderate or severe hepatic dysfunction. METHODS: Retrospective chart review of hospitalized patients atMayo Clinic in Rochester, Minnesota between June 2010 and May2011. Patients 18 years of age or older who received two or moredoses of anidulafungin and consented for research were included. Datacollected pertained to demographics and liver function. Mild elevationin liver function tests (LFTs) was defined as aspartateaminotransferase (AST) or alanine aminotransferase (ALT) 1–2 timesthe upper limit of normal. In the absence of definitive stratificationcriteria, patients without hyperbilirubinemia (bilirubin >2 mg/dL) andmild LFT elevation were considered to have mild hepaticinsufficiency. Moderate to severe hepatic dysfunction was defined asLFTs >3 times the upper limit of normal or hyperbilirubinemia. RESULTS: There were 81 episodes of anidulafungin use in 74patients during the study period. Population median (IQR) AST, ALTand total bilirubin values were 109 (47–256) U/L, 86 (38–144) U/L,and 2.3 (0.9–8.7) mg/dL, respectively. In 12 instances (15%), patientsreceiving anidulafungin had normal LFTs without hyperbilirubinemia,while 17 patients (21%) had only mild hepatic insufficiency. CONCLUSION: Anidulafungin is used as an alternative tocaspofungin in patients with hepatic dysfunction due to lack of hepaticmetabolism and seemingly insufficient knowledge and familiarity withcaspofungin pharmacokinetics in this population. Our institutionalpolicy reserves anidulafungin for patients with moderate or severehepatic dysfunction. In the present investigation, 36% of its use was inpatients with normal or mildly decreased hepatic function. Thisrepresents an opportunity to improve discrimination between mild andmoderate or severe hepatic dysfunction. Such delineation mayimprove compliance to formulary restrictions where they have beenimplemented.

372. Does in-vitro resistance of Streptococcus pyogenes toerythromycin produce clindamycin resistance?Christine M. Bridgen, Pharm.D., Harminder Sikand, Pharm.D., DanielKeays, M.S., C.L.S.; Scripps Mercy Hospital, San Diego, CA PURPOSE: Throughout the last decade there has been a trend of

increasing macrolide resistance to Streptococcus pyogenes (Group AStrep), which is responsible for severe, life-threatening infectionsincluding toxic shock syndrome and necrotizing fasciitis. Recent datain 2010 from Scripps Mercy Hospital in San Diego, California showeda rate of 20% macrolide resistance to S. pyogenes. This data promptedfurther investigation, the main concern being that macrolide resistancewould produce cross-resistance in clindamycin. Our primary objectivewas to determine the prevalence of erythromycin and clindamycinresistance among clinical isolates of S. pyogenes in the San Diego areaand determine the mechanism of resistance, whether that be throughdrug inactivation, efflux pumps or methylation. METHODS: 146 consecutive isolates of S. pyogenes were analyzedfrom five Scripps hospitals. The antimicrobial susceptibilities of theisolates were determined using double-disk diffusion testing (d-test).Analysis was performed using a two-sample test of proportions (2-tailed). A p<0.05 will be considered significant for all statisticalanalysis. RESULTS: 146 strains of S. pyogenes were analyzed for botherythromycin and clindamycin susceptibility. There was nostatistically significant difference between the resistance patterns oferythromycin or clindamycin to S. pyogenes (28 vs 27, p=0.88).Overall, there were 27 positive d-tests, demonstrating that the mainmechanism of resistance produced by S. pyogenes in the San Diegoarea was through methylation which causes resistance to botherythromycin and clindamycin. CONCLUSIONS: S. pyogenes is resistant to both erythromycin andclindamycin in ~20% of strains in the San Diego area. If a patient isresistant to erythromycin there is a high likelihood it will also beresistant to clindamycin. With the increasing trend of macrolideresistance in S. pyogenes strains, the penicillin family remains thedrug of choice in these infections and macrolide use should bereserved for patients with true beta lactam allergies.

373. A matched-controlled evaluation of an antifungal bundle inthe intensive care unit at a university teaching hospital. Anthony J.Guarascio, Pharm.D.1, Douglas Slain, Pharm.D., BCPS1, ArifSarwari, M.D.1, Richard L. McKnight, Pharm.D.2, Karen O. Petros,Pharm.D.2, John Parker, M.D., FACP, FCCP2, Alison M. Wilson,M.D.1, Maria Pompili, Pharm.D.2, Melissa L. Rinehart, Pharm.D.2,Carrie Defazio, Pharm.D.2; (1)West Virginia University, Morgantown,WV; (2)West Virginia University Hospitals, Morgantown, WV PURPOSE: Care bundles have recently become importantantimicrobial stewardship efforts. Echinocandins are expensiveantifungals that are often overutilized in the ICU. We implemented anantifungal bundle to encourage appropriate use of these antifungals.The primary objective of this study is to assess the utility of anantifungal bundle that specifically targets caspofungin use in the ICU.METHODS: This is a matched-controlled study of 75 adult patientsprescribed caspofungin in the ICU. The antifungal bundle wasimplemented over a five-month time period in 2011. Bundle patientswere compared to control patients who received treatment within atwo year period prior to initiation of the bundle protocol. Patients werematched based on age, gender, ICU service, indication, and modifiedAPACHE II score in a 1:2 ratio. Key components of the bundleinclude assessment of indication, dose, interval, and planned duration. RESULTS: We found a significant difference in median days oftherapy (4.5 vs. 2.0 days, p=0.005) for caspofungin use before andafter bundle implementation. Most of this reduction in use wasrealized in the medical ICU (p=0.02) as opposed to the surgical ICU(p=0.54). Based on average wholesale price (AWP), these findingsreflect a median cost savings of approximately $1,013/patient.Although adherence to bundle criteria was higher in the medical ICUcompared to the surgical ICU, these differences were not statisticallysignificant (76% vs. 50%, respectively; p=0.36). Of 25 patientsreceiving caspofungin during the bundle period, three were de-escalated to fluconazole and 13 had antifungal therapy discontinuedwithin 3 days. Eleven of these patients had yeast culture growth fromBAL or urine specimens. None of the patients in the bundleimplementation group experienced recurrence or death from a fungalinfection. CONCLUSION: Use of an antifungal bundle approach appears tofacilitate a reduction in echinocandin use in the ICU without adverselyaffecting patient outcomes.

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374. Doripenem and colistin is synergistic and demonstratesbactericidal killing against pandrug-resistant Klebsiellapneumonia isolates in vitro. Meredith Jernigan, Pharm.D., Minh-Hong Nguyen, M.D., Neil Clancy, M.D., Ellen Press, B.S., RyanShields, Pharm.D.; University of Pittsburgh Medical Center,Pittsburgh, PA PURPOSE: Carbapenem-resistant Klebsiella pneumonia (KPC) is amajor cause of disease at our center, and many isolates havedeveloped resistance to salvage agents such as colistin (COL). Wesought to identify the preferred antimicrobial combination fortreatment of KPC disease by evaluating in vitro synergy. METHODS: 11 unique KPC isolates were tested by time-kill assaysusing combinations of doripenem (DOR), COL, gentamicin (GEN),and doxycycline (DOX) at clinically achievable concentrations. RESULTS: All isolates were non-susceptible to DOR. MIC50/MIC90for COL, DOX, and GENT were 8/64, 6/16, and 32/64 µg/mL,respectively. 9/11 (82%) were COL-resistant, 9/11 were GEN-resistant, and 7/11 (64%) were resistant to all agents. Synergy (≥ 1 logCFU/mL greater kill in combination vs most active single drug) wasidentified with DOR+COL, GEN+DOX, DOR+GEN, DOR+DOX,COL+GEN, and COL+DOX against 10/11 (91%), 4/9 (44%), 4/9(44%), 4/11 (36%), 3/9 (33%), and 3/11 (27%), respectively. OnlyDOR+COL resulted in a reduction of starting inocula for all isolates(log-kill range: 0.3 – 5.8 CFU/mL) and was bactericidal (≥ 2 logcFu/mL kill) against 6/11 (55%). Among synergistic combinations, themost rapid kills were with COL+GEN and COL+DOR (mean areasunder the bactericidal curve [AUBC]: 59.8 and 77.5; p=NS). Bothcombinations were superior to DOR+DOX (129.4; p=0.031 and0.049, respectively). Antagonism (less kill in combination) wasevident for COL+DOX and COL+GENT against 4/11 (36%) and 2/11(18%), respectively. The in vitro data are consistent with ourpreliminary clinical experience in transplant recipients, in whomCOL+carbapenem combinations are more effective than alternativecombinations. CONCLUSION: DOR+COL demonstrated excellent in vitro activityagainst pandrug-resistant KPC isolates. COL+GEN is rapidlybactericidal against some isolates, but antagonistic against others andclinically limited by additive toxicity. Following completion of thispilot study, DOR+COL has become the first-line treatment for KPC atour center and clinical outcomes are being evaluated prospectively.

Managed Care

375. Evaluation of a fluticasone/salmeterol step-down program.Lily Phuong, Pharm.D., Emily Pearse, Pharm.D., Judy Pereira,Pharm.D., Fern Chau-Devera, Pharm.D.; Kaiser Permanente MedicalCare Program, Vallejo, CA PURPOSE: In 2010, the Food and Drug Administration mandatedlabeling changes that recommend stepping down long acting b-agonist(LABA) use in patients with well-controlled asthma due to increasedrisk of asthma-related death with LABA monotherapy. Primary carepharmacists collaborated with providers to develop afluticasone/salmeterol (F/S) Step-Down Program to decreaseunnecessary LABA use in patients with stable asthma. The primaryendpoint is to determine the rate of change in F/S use afterimplementing the F/S Step-Down Program in 2010 compared toprevious years. Secondary endpoints include identifying the patientpopulations that could most successfully step-down F/S use andreviewing barriers to the program. METHODS: This is a retrospective study lasting from January toDecember 2010. Pharmacists started the outreach under the F/S step-down protocol. Patients who met inclusion and exclusion criteria weresubdivided into three populations: Low, Moderate, and High F/S users.The yearly rates of F/S use from 2006 to 2010 were calculated. RESULTS: In 2009, the number of patients on F/S normalized to permember per month per thousand (PMPMK) was 14.39. In 2010, it was14.36, a small decrease in F/S usage by 0.2%. It was also found thatLow and Moderate F/S users were more successful than High F/Susers, p<0.001. No significant differences in success between Low andModerate F/S users, p=0.08. Some barriers to the step down programincluded the inability to contact patients and providing outreach whentheir asthma was exacerbated due to allergies, cold, or flu. CONCLUSION: After implementation of the program, F/S usage

decreased for the first time in years. Low and Moderate users are moresuccessful than High users. One solution to overcome barriers is toprovide outreach to patients during the time of the year when asthmais more stable to educate on asthma management to preventexacerbation.

Medication Safety

376. Avoidance of sulfonylureas in hospitalized patients at highrisk for hypoglycemia: effectiveness of an email alert. IbrahimSales, Pharm.D., Donihi Amy, Pharm.D., BCPS; University ofPittsburgh Medical Center, Pittsburgh, PA PURPOSE: Patients of advanced age and those with renalinsufficiency are at increased risk for hypoglycemia when usingsulfonylureas. A Quality Improvement project was designed todetermine if an email alert prompted discontinuation of sulfonylureasin hospitalized patients at risk for sulfonylurea-related hypoglycemia. METHODS: The hospital’s medical director sent an email alert to theattending physician of patients (n=64) ordered a sulfonylurea whilehospitalized from July – September 2010. The following data wereretrospectively collected from patients’ medical records: patient age,serum creatinine (SCr), and incidence of hypoglycemia (glucose <70mg/dL). The prevalence of risk factors (age ≥65 and SCr ≥2 mg/dL) inhypoglycemic patients was compared to the prevalence in patientswithout hypoglycemia. RESULTS: Email alerts were sent for 22 (32%), 32 (19%), and 10(30%) patients taking glyburide, glipizide, and glimepiriderespectively. Fifty-five patients (86%) continued the sulfonylureadespite the alert, 5 patient orders (8%) were discontinued within 24hours of the alert, 2 (3%) were discontinued after 24 hours, and 2 (3%)were discontinued prior to the alert. Seventeen patients (27%)experienced a total of 31 episodes of hypoglycemia. Of the patientswith hypoglycemia, 9 (53%) were ≥65, 6 (35%) had SCr ≥2, and 10(59%) were either of advanced age or with renal insufficiency. Of the47 patients who did not experience hypoglycemia, 31 (66%) were ≥65,11 (23%) had SCr ≥2, and 36 (77%) were either of advanced age orwith renal insufficiency. There were no statistical differences betweengroups. CONCLUSION: Use of an email alert was not effective in promptingdiscontinuation of sulfonylureas in the hospital. Alternative strategiesfor preventing sulfonylurea-related hypoglycemia are needed. Inaddition, proposed risk factors for hypoglycemia may not accuratelyidentify hospitalized patients predisposed to hypoglycemia suggestingthat sulfonylureas should be avoided in all patients in the hospitalsetting.

377. Creation of a risk score for predicting opioid harm in theinpatient setting. Jordan R. Wong, Pharm.D., Nadia Z. Haque,Pharm.D., Megan Winegardner, Pharm.D., James S. Kalus, Pharm.D.;Henry Ford Hospital, Detroit, MI PURPOSE: Opioid medications are the medication class mostcommonly associated with significant errors in the hospital setting.The purpose of this study was to create and validate a risk score forpredicting naloxone use, a surrogate marker for serious opioid harm,for the inpatient setting. METHODS: Medical records of 300 patients, receiving opioids andadmitted to an inpatient hospital setting between July 2009 andDecember 2009, were abstracted to identify variables associated withnaloxone use. From this evaluation, a risk score was developed topredict the use of naloxone. This risk score was based on the oddsratios derived from a multivariate analysis. One point was assigned forage > 65 years, opioid-naïve status, non-African American race, andchronic obstructive pulmonary disease. Two points were given for thepresence of renal failure. The risk score was then validated in adifferent patient population (n = 300) receiving opioids and admittedbetween April 2010 – December 2010. RESULTS: Risk for naloxone use increased with increasing riskscore. Naloxone use at each risk score was: 0 = 8.7%, 1 = 11.1%, 2 =30.3%, 3 = 38.6%, 4 = 46.8%, 5 = 59.1%, 6 = 100%. The area underthe curve for the receiver operating characteristic (ROC) curve was0.701 with 95% confidence interval of 0.640-0.762 (p<0.05). Thesensitivity and specificity of a risk score greater than or equal to 3 was72% and 57.5%, respectively. A risk score cut-point of greater than or


equal to 4 yielded a sensitivity of 45% and a specificity of 79%. CONCLUSION: This opioid harm risk score provided moderatepredictive ability for identifying patients at risk for opioid-relatedadverse events. This risk score could be useful as a screening tool forhospitalized inpatients receiving opioid therapy.

Nephrology

378. Daily home hemodialysis versus conventional in-centerhemodialysis: evaluation of biomarkers of vascular calcificationand management of mineral and bone disorder. Magdalene M.Assimon, Pharm.D.1, Page V. Salenger, M.D.2, Shari Meola, RN2,Darius L. Mason, Pharm.D., BCPS1; (1)Albany College of Pharmacy& Health Sciences, Albany, NY; (2)Rubin Dialysis Center, CliftonPark, NY PURPOSE: Hyperphosphatemia contributes to the pathogenesis ofvascular calcification (VC). Daily home hemodialysis (DHHD) clearsphosphorus more effectively than conventional in-center hemodialysis(IHD), resulting in reduced phosphate binder requirements andpossible attenuation of VC. The aims of this study were to characterizeconcentrations of VC biomarkers among DHHD and IHD patients andto explore the management of mineral and bone disorder (MBD).METHODS: Adult hemodialysis patients were included in this pilotstudy. For every DHHD patient enrolled, an age (±5 years), sex anddialysis vintage (±6 months) matched IHD patient was selected.Patient demographics, laboratory parameters and medication regimenswere obtained. Pre-dialysis concentrations of VC biomarkers (FGF-23, fetuin A and osteoprotegrin) were determined using ELISA.RESULTS: Forty patients were included in this analysis (20 DHHDand 20 IHD). Phosphorus (4.8±1.3 mg/dl versus 6.5±1.9 mg/dl,p=0.002) and PTH (211.2 [30.6–144] pg/ml versus 395 [141.4-1,388.6] pg/ml, p=0.034) levels were lower among DHHD patients,whereas calcium (9.2±0.5 mg/dl versus 8.9±0.6, p=0.049)concentrations were higher in the DHHD group. FGF-23concentrations were lower among DHHD patients (397 [55.9–1,572.3]pg/ml versus 501.8 [177.3–4,775.2] pg/ml, p=0.0340), whereas fetuinA levels were higher among DHHD patients (1.57±0.44 g/L versus1.02±0.69 g/L). No differences in osteoprotegrin concentrations wereobserved. A lower proportion of DHHD patients were using phosphatebinders (60% versus 90%, p=0.029). Vitamin D analog and cinacalcetuse was similar between groups. CONCLUSIONS: These datasuggest superior control of serum phosphorus and MBD amongDHHD patients, despite a smaller percentage of patients on phosphatebinding therapy and use of similar doses of MBD medicationscompared to IHD patients. Additionally, lower FGF-23 and higherfetuin A concentrations observed in the DHHD group suggests a lowerVC burden and warrants further investigation.

Neurology

379. Examining utilization patterns of patients receiving oraltherapy for multiple sclerosis (MS) treatment. Laura Studnicki,Pharm.D., M.B.A. Candidate1, Pamela H. Koerner, Pharm.D.2,Richard T. Miller, R.Ph., M.B.A.3; (1)Walgreens, Co. and DuquesneUniversity, Mylan School of Pharmacy, Pittsburgh, PA; (2)DuquesneUniversity, Mylan School of Pharmacy, Pittsburgh, PA; (3)Walgreens,Co, Carnegie, PA PURPOSE: With the introduction of the first oral therapeutic agentfor MS treatment in late 2010, a study was initiated to evaluate MSpatients receiving fingolimod therapy within Walgreens SpecialtyPharmacy. With minimal published utilization data available the intentis to 1) identify demographics of the patient population currentlyutilizing the medication, 2) evaluate common side effects that patientsare experiencing, and 3) review historical MS treatments in patientsthat were switched to oral therapy and the reasons why the initialtherapy was altered. METHODS: Patients receiving fingolimod therapy from any of ourfive Walgreens Co. specialty pharmacy locations, beginning onNovember 16, 2010, will be retrospectively reviewed. Initialassessments will include: age, gender, MS type, time since diagnosisand whether or not the patient was new to fingolimod therapy. Follow-up assessments, conducted monthly, identifies patient reported sideeffects, falls, missed doses, reasons for missing doses and if new

assistive devices have been used in the past month. MedicationPossession Ratio (MPR) will also be determined for these patientswhen on therapy for at least 6 months. RESULTS: A total of 537 fingolimod patients are currently beinganalyzed. Women have a greater utilization rate (78.2%) whencompared to men (21.8%). Relapsing remitting MS patientsencompass 70% of the population, with secondary progressive at 2.8%and progressive relapsing at 2.2%. Twenty-five percent of cases didnot report their MS type. Time since diagnosis was defined as follows:0 to 6 months (5.9%), 7 to 11 months (1.7%), 1 to 5 years (26.3%), 6to 10 years (20.3%), >10 years (35.4%) and uncertain (10.4%). CONCLUSION: Based on the drug release date and the timing of theassessments to be conducted, data collection and analysis will becompleted by August 2011. This data will include demographicinformation, adverse drug events reported and MPR.

Oncology

380. Isotope dilution mass spectrometry influence on calculatingcarboplatin doses. Rachelle Whiteside, Pharm.D., Rickey Miller,Pharm.D., BCPS, BCOP, Kenneth Kochman, Pharm.D.; AlleghenyGeneral Hospital, Pittsburgh, PA PURPOSE: Carboplatin dosing relies heavily on the accuracy ofserum creatinine measures and its effect on calculating creatinineclearance. Allegheny General Hospital adopted the new standard ofisotope dilution mass spectrometry (IDMS) for measuring serumcreatinine in February 2009. Current equations for determiningcreatinine clearance do not take into account this standardization andan equation was developed to “correct” the serum creatinine. Thepurpose of this study is to determine the effect of IDMSstandardization on area under the curve (AUC) dosing of carboplatin. METHODS: Medical records of 232 patients who receivedcarboplatin for a variety of malignancies were identified over a threeyear period. Patients were included if they received at least one doseof carboplatin. All doses of carboplatin received were analyzed.Patients AUC, dose, growth factor utilization, platelet transfusionrequirements, platelet count, and absolute neutrophil count (ANC)were also documented. RESULTS: The median dose without correction was 308 mg and withIDMS correction was 279 mg in the post-IDMS group resulting in apercent change in dosing of 9.2%. The patient’s dose was compared tothe Cancer Therapy Evaluation Program/National Cancer Institute(CTEP/NCI) maximum dosing. In patients with an AUC of 4, 50% ofdoses were above CTEP/NCI recommendations in the pre-IDMSgroup and 67% in the post-IDMS group. In patients with an AUC of 6,5.3% of doses were above recommendations in the pre-IDMS groupand 36.8% in the post-IDMS group. CONCLUSION: There is approximately a 10% increase incarboplatin dosing depending on the AUC in post-IDMS patients if thecorrection factor of serum creatinine is not utilized when calculatingthe creatinine clearance. IDMS standardization of serum creatininemay result in an overestimation of creatinine clearance. As a result,larger doses of carboplatin may be prescribed potentially increasingthe risk of developing toxicities.


381. The effect of epithelial sodium channel genotype on loopdiuretic requirements in systolic heart failure; interim analysis ofthe first 50 subjects. Adam P. Bress, Pharm.D., Vicki L. Groo,Pharm.D., Robert J. DiDomenico, Pharm.D., Thomas D. Stamos,M.D., Shital Patel, M.S., Larisa H. Cavallari, Pharm.D.; University ofIllinois at Chicago, Chicago, IL PURPOSE: Response to loop diuretics (LD) in patients with heartfailure (HF) is highly variable. Variation in the SCNN1G and SCNN1Bgenes, which encode for the epithelial sodium channel gamma andbeta subunits, respectively, have been associated with altered responseto LDs in healthy subjects. The purpose of this study is to determine ifthe SCNN1G rs5729 T>A, variants influence oral LD requirements inHF patients.METHODS: Adult patients with HF and systolic dysfunction treatedwith stable doses of HF medications, including oral LD, for ≥4 weeksare eligible for this prospective cohort study. Patients with significant

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renal or hepatic dysfunction are excluded. Target enrollment is 100patients. Patient characteristics and a buccal cell sample for geneticanalysis are collected. Loop diuretic dose requirements will becompared between SCNN1G rs5729 T>A variant allele carriers andnon-carriers. We will also compare the prevalence of high dosediuretic therapy, defined as requiring >80mg/day of furosemide (orequivalent doses of other LDs) or the combination of any LD andmetolazone, between genotype groups. RESULTS: A total of 50 subjects have been enrolled to date, with amean age of 58±11 years and mean left ventricular ejection fraction of22±7%. The majority (92%) have NYHA class II or III HF. Thers5729A allele frequency is 0.27. The median (IQR) daily LD dose(furosemide equivalents) is 80 (40-120) mg/day in variant allelecarriers and 80 (40-160) mg/day in non-carriers. High dose LD wasrequired in 10 (40%) variant carriers compared to 9 (36%) non-carriers. CONCLUSION: Recruitment is on-going, but data to date suggestthat, in contrast to data in healthy subjects, the rs5729 T>A variantmakes no contribution to LD requirements in HF.


382. Prospective trial of a novel vancomycin nomogram. Amber R.Wesner, Pharm.D.1, Robert S. Kidd, Pharm.D., Ph.D.2, Marcia L.Brackbill, Pharm.D., BCPS2, Larissa Coyle, Pharm.D., BCPS3;(1)Shenandoah Univeristy, Bernard J. Dunn School of Pharmacy /Valley Health, Winchester Medical Center, Winchester, VA;(2)Shenandoah University, Bernard J. Dunn School of Pharmacy,Winchester, VA; (3)Valley Health, Winchester Medical Center,Winchester, VA PURPOSE: Revised guidelines for appropriate vancomycin troughconcentrations were published in 2009 defining appropriate troughconcentrations from 10–20 µg/mL. Available nomograms were notdesigned to achieve these higher trough levels. The purpose of thisstudy is to prospectively evaluate a novel vancomycin nomogrampreviously validated retrospectively at our institution. METHODS: This was a prospective, open-label study at a 411-bedcommunity hospital. Patients were included if they were >18 y, ≤120kg, and had an order for pharmacy-dosed vancomycin. Patients wererandomized to be dosed using the new nomogram, or to be dosedusing traditional pharmacokinetic calculations. It was calculated that414 patients would need to be enrolled. The primary objective was tocompare the percentage of patients achieving an initial therapeuticvancomycin trough. Therapeutic troughs were defined as being drawnat steady state and falling between 10-15 or 15-20 mcg/mL based onthe indication for therapy. Secondary objectives were to compare theabsolute difference between desired and actual troughs measured andto assess pharmacist’s opinions of the nomogram. RESULTS: To date 157 patients have been enrolled and recruitmentis ongoing. Preliminary results found traditional dosing achievedtherapeutic troughs in 34% of patients and nomogram dosing achievedtherapeutic troughs in 49% of patients (n=157; p=0.112). Nomogramdosing was superior to traditional dosing in the 15–20 µg/mL troughrange (n=101; p=0.025), but was not statistically significant in the10–15 µg/mL trough range (n=56; p=0.794). There was not asignificant difference between groups for the absolute differencebetween trough measurements, and pharmacists’ agreed that thenomogram saved them time. CONCLUSION: Preliminary results did not find a statisticallysignificant difference between methods in achieving initial therapeuticvancomycin troughs although results are trending towardssignificance. Data collection is continuing to determine if results willbecome significant as the required number of patients are enrolled toachieve power.


383. Tacrolimus trough concentrations in heart transplantrecipients during episodes of acute cellular rejection. GretchenKipp, Pharm.D.1, Michael A. Shullo, Pharm.D.1, Heather J. Johnson,Pharm.D., BCPS1, Shelby L. Corman, Pharm.D., BCPS1, JeffreyTeuteberg, M.D.2, Ty Ridenour, Ph.D.3, Raman Venkataramanan,

Ph.D.3; (1)UPMC Department of Pharmacy & Therapeutics,Pittsburgh, PA; (2)UPMC Cardiovascular Institute, Pittsburgh, PA;(3)University of Pittsburgh, Pittsburgh, PA PURPOSE: Approximately 20–40% of heart transplant recipientsexperience an episode of acute cellular rejection (ACR) within theirfirst year after transplant. Pro-inflammatory cytokines involved inACR are thought to down regulate the metabolism of tacrolimuscausing clinically significant fluctuations in tacrolimus levels.Therefore, the primary aim of this research study was to describetacrolimus whole blood trough concentrations during episodes of ACRin orthotopic heart transplant (OHT) recipients. The secondary aimwas to determine whether elevated tacrolimus trough concentrationsduring ACR are associated with markers of tacrolimus toxicity. METHODS: This retrospective cohort study was designed to describetacrolimus trough concentrations before, during and after episodes ofACR. The first part of the study used an A-B-A study design tocompare the mean dose-normalized tacrolimus trough concentrationsin each patient before, during and after resolution of an episode ofACR. The second part of the study compared serum creatinine, bloodurea nitrogen and potassium concentrations at the same time points. RESULTS: A total of 129 heart transplant recipients experienced atleast one episode of ACR within their first year post transplant butonly 34 patients had complete dose-normalized tacrolimusconcentrations available for the primary analysis. The dose-normalized concentrations were 0.793, 0.875 and 0.890 (ng/mL)/mgbefore, during and after episodes of ACR, respectively (p=0.383).Potassium concentrations were 4.41, 4.41 and 4.38 mEq/L for therespective time points (p=0.59). Serum creatinine concentrations were1.60, 1.57 and 1.61 mg/dL (p=0.71) and BUN concentrations were32.4, 31.1 and 33.4 mg/dL before, during and after ACR, respectively(p=0.25). CONCLUSION: The results suggest that tacrolimus metabolism isnot significantly altered during episodes of ACR in OHT recipients.Additional data collection and generalized mixed model growth curveanalyses are ongoing.

384. Early Corticosteroid Withdrawal Reduces Risk for ActualCardiovascular Events in Renal Transplant Recipients: AMultivariate Analysis. Nicole M. Schmidt, Pharm.D., E. SteveWoodle, M.D., Rita R. Alloway, Pharm.D., Gautham Mogilishetty,M.D., Amit Tevar, M.D., Stefanie Young, Liz Cole, Dennis Hanseman,M.S., Adele R. Shields, Pharm.D.; University of Cincinnati,Cincinnati, OH PURPOSE: Early corticosteroid withdrawal (ECSWD) has beenshown to mitigate several known cardiovascular risk factors inprospective clinical trials. We have recently demonstrated thatECSWD also reduces cardiovascular events (CVE) in a large cohort of1004 renal transplant recipients. This study examined risk factors forCVE, including ECSWD, in a multivariate analysis (MVA) in renaltransplant recipients. METHODS: Data was prospectively collected from 1998-2010 onCVE, cardiovascular risk factors, and transplant-related risk factors atbaseline, 1, 3, 6 months, then yearly in 1004 renal transplantrecipients. CVE included angina, cerebrovascular accident/transientischemic attack, myocardial infarction, coronary heartdisease/ischemic event, cardiovascular procedure, and cardiovasculardeath/sudden death. Statistical analyses included c2, student t-test, andMVA using logistic regression. Factors with a p ≤ 0.1 in the univariateanalysis (UVA) entered the final MVA model. RESULTS: 714 patients received ECSWD and 290 patients receivedchronic corticosteroid regimens. 267 CVE occurred in 171 patients. UVA of Risk Factors for CVE p-value Age (years) 0.0412 African American Race 0.0617 Pre-Transplant Dialysis 0.0028 Smoking 0.0044 Pre-Transplant CAD 0.0003 Pre-Transplant DM <0.0001 Acute Rejection 0.0215 New Onset Diabetes After Transplantation 0.0688 Pre-Transplant SBP (mmHg) 0.0070 Mean Post-Transplant SBP (mmHg) 0.0074 Mean Post-Transplant # Hypertension Medications 0.0212


Mean Post-Transplant SCr (mg/dL) 0.0142 Mean Post-Transplant Total Cholesterol (mg/dL)

0.0128 Mean Post-Transplant Triglycerides (mg/dL) 0.0231 ECSWD <0.0001

Final MVA Model Odds Ratio p-value Pre-Transplant DM 2.686 <0.0001 Smoking 1.880 0.0024 Pre-Transplant CAD 1.529 0.0637 ECSWD 0.459 <0.0001CONCLUSION: Risk factors significant for CVE in the MVA modelincluded traditional cardiovascular risk factors of smoking, pre-transplant DM and preexisting CAD. In addition, ECSWD was foundto reduce CVE risk by over 50%. In summary, this long termexperience, when multiple risk factors are adjusted, provides strongevidence for a protective effect of ECSWD on CVE.

385. 10-Year Experience with Early Corticosteroid Elimination inKidney Transplantation: Analysis of Patient and Graft Survival.Nicole M. Schmidt, Pharm.D.1, Adele R. Shields, Pharm.D.1, Rita R.Alloway, Pharm.D.1, Gautham Mogilishetty, M.D.1, Michael Cardi,M.D.2, Rino Munda, M.D.2, Amit Tevar, M.D.1, Justin Burns, M.D.1,Joseph Kremer, M.D.2, Liz Cole1, Stefanie Young1, Dennis Hanseman,M.S.1, Shahzad Safdar, M.D.2, E. Steve Woodle, M.D.1; (1)Universityof Cincinnati, Cincinnati, OH; (2)The Christ Hospital, Cincinnati, OH PURPOSE: Early corticosteroid withdrawal (ECSWD) reducescardiovascular risk, however long term effects on patient and graftsurvival have not been established. The purpose of this study was toevaluate long term effects of ECSWD on patient and graft survival. METHODS: Prospectively collected data (from 1998–2010) in 1004renal transplant patients (714 ECSWD and 290 chronic corticosteroid(CCS) patients) was analyzed. Statistics included c2 test, student t-test,and Kaplan-Meier (KM) survival analyses using log rank. RESULTS: Mean corticosteroid dose in the CCS group at 1 year was6.9 ± 5.5 mg and 5 ± 1.6 mg at 4 years. Median follow-up was 1527(1–3762) days in ECSWD and 2147 (2–4720) days in CCS. ECSWDwere older, with more males, fewer African Americans, but with morepreexisting coronary artery disease and diabetes. KM analysesdemonstrated that ECSWD patients experienced significantly lesscardiovascular events (CVE), but no difference in patient survival,cardiovascular-related death, non-cardiovascular related death, orcancer-related death compared to CCS patients. KM analysisdemonstrated a trend toward less infection-related death (p=0.09) andnumerically higher death-censored graft survival (p=0.06) withECSWD patients. 10-Year Kaplan ECSWD CCSMeier Estimates (n=714) (n=290) p-value CVE Rate 24.0% 35.0% 0.02 Patient Survival 76.0% 76.0% NS Cardiovascular Related Death 15.0% 15.0% NS Non-Cardiovascular Related Death 13.0% 12.5% NS Infection-Related Death 0.8% 2.4% 0.09 Cancer-Related Death 5.0% 3.8% NS Acute Rejection 24.0% 27.0% NS 1-Year Acute Rejection 13.2% 16.9% NS Antibody-Mediated Rejection 2.4% 2.8% NS Overall Graft Survival 60.0% 54.0% NS Death-Censored Graft Survival 81.0% 68.0% 0.06CONCLUSIONS: KM 10 year data demonstrates that ECSWDpatients experience lower CVE and higher death-censored graftsurvival rates. However, overall patient survival was similar betweengroups. In summary, this 10 year experience demonstrates substantialbenefits for ECSWD patients with respect to CVE and death-censoredgraft survival.

386. Multivariate analysis of risk factors that influence graftsurvival following proteasome inhibitor therapy for antibodymediated rejection. Basma Sadaka, Pharm.D., Rita R. Alloway,Pharm.D., Alin Girnita, M.D., Paul Brailey, Ph.D., GauthamMogilishetty, M.D., E. Steve Woodle, M.D.; University of Cincinnati,Cincinnati, OH PURPOSE: Antibody (Ab)-mediated rejection (AMR) with presence

of DeNovo Donor Specific Ab (DSA) is associated with a 6.6-foldincrease in risk for allograft loss. Recently, our center has pioneeredthe use of bortezomib to reduce DSA by depleting plasma cells,offering alternative treatment options. The purpose of this study was todefine factors influencing graft loss in a large single center experiencewith proteasome inhibitor (PI) therapy for AMR. METHODS: 42 renal transplant recipients diagnosed with AMR weretreated with bortezomib 1.3 mg/m2x4 doses. Immunodominant DSA(iDSA) is the HLA Ab with highest MFI value at the time of AMRdiagnosis. Factors evaluated in the univariate analysis (UVA) with p-value<0.1 were incorporated in the logistic regression model. RESULTS: Demographic, histologic, immunologic, and functionaloutcome data post treatment will be presented. Overall patient andgraph survival were 97.6% and 73.8%, respectively. Non-significantfactors in the UVA included: age>60, female gender, AA race, class IDSA and DQ iDSA specificity, and pre-treatment iDSA level.Significant factors in the UVA were analyzed in the MVA model:

UVA MVAOR p-value OR p-value

Serum Creatinine (SrCr) returned to 15% of baseline at day 14 5.464 0.0486 10.723 0.0372

iDSA reduction >25% at day 14 4.083 0.0582 0.234 0.1390

Histologic improvement within 7-14 days 3.719 0.0837 5.108 0.1044

Compliance 7.291 0.0103 7.113 0.0544

CONCLUSION: SrCr was a factor that influenced renal allograftsurvival following PI therapy. The positive effect of compliance alsoapproached statistical significance. These factors may be useful forpredicting long-term outcomes and determining which patients needadditional or more aggressive AMR therapy.

387. Preservation of renal function with angiotensin convertingenzyme inhibitor or angiotensin receptor blocker therapy earlyafter heart transplantation. David Johnson, Pharm.D., Michael AShullo, Pharm.D., Shelby L. Corman, Pharm.D., M.S., BCPS, JeffreyJ. Teuteberg, M.D.; University of Pittsburgh, Pittsburgh, PA PURPOSE: Nearly a third of orthotopic heart transplant (OHT)recipients develop renal failure within a year of transplantation. Post-OHT renal dysfunction secondary to calcineurin inhibitors (CNI) is aleading cause of renal impairment after transplantation. Severalexisting CNI minimization strategies have demonstrated protectionagainst CNI induced nephrotoxicity; however, few preemptive, non-immune suppressive strategies exist. The aim of our study was todetermine if early treatment with angiotensin-converting-enzyme-inhibitor/angiotensin-receptor-blocker (ACEi/ARB) therapy afterOHT is asssociated with improved renal function in patients receivingCNI. METHODS: Male and female patients ≥ 18 years old wereretrospectively divided into two groups: patients who had initiated/ARB therapy within 90 days of transplantation or patients who didnot receive /ARB within 90 days of transplantation. Patients surviving< 90 days after transplantation, receiving a second heart transplant orwho had a GFR ≤ 30 ml/min/1.73m2 within the first 90 days oftransplantation were excluded from the study. The primary endpointwas the time-to a ≥30% reduction in baseline GFR. Secondaryendpoints included time-to a GFR ≤ 30 ml/min/1.73m2 and all-causemortality. RESULTS: A total of 315 patients were included in the study, 147 inthe non ACEi/ARB group and 168 in the ACEi/ARB group. Bothgroups were similar, however, more patients in the ACEi/ARB groupreceived MMF compared to the non ACEi/ARB group (p<0.001).There was no difference in the time to ≥30% reduction in GFR(p=0.385) or time to GFR ≤ 30 ml/min/1.73m2 (p=0.957) betweenstudy groups. However, there was a mortality benefit in patientsreceiving ACEi/ARB therapy (p=0.045); however, after adjusting foruse of MMF these was no longer signifcant, (p=0.397). CONCLUSION: Early initiation of /ARB therapy did notdemonstrate a renal benefit in OHT patients receiving CNI aftertransplantation. No mortality benefit was observed when the groupswere adjusted for MMF use.

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STUDENT SUBMISSIONS


388. A description of antibiotic-related laboratory interferences.Thomas J. Wolfel, B.S., Pharm.D., 2012, Candidate1, Sandra Kane-Gill, Pharm.D., M.S., FCCM1, Pamela Smithburger, Pharm.D.2,Megan D. Schultz, Pharm.D., 2012, Candidate1, Cortlynn Latsha,Pharm.D., 2012, Candidate1, Lauren M. Fisher, Pharm.D., 2012,Candidate1, Ashley N. Hogue, Pharm.D., 2012, Candidate1;(1)University of Pittsburgh School of Pharmacy, Pittsburgh, PA;(2)UPMC Presbyterian, Pittsburgh, PA PURPOSE: Many medications, including antibiotics, interfere withlaboratory tests resulting in false results. With the abundant use ofantibiotics, there is a need to collectively evaluate the interferingantibiotics and the laboratory tests effected which is the purpose ofthis evaluation. METHODS: A literature research of Medline was conducted from1948–2009 for terms “drug,” “interaction or interference,” and“laboratory.” A total of 75 articles pertaining to antibiotic-labinterferences were reviewed. Articles were evaluated by 5 students forthe laboratory test being studied, interfering antibiotic, the interferencecaused, and mechanism of the interference. RESULTS: The class of antibiotics that accounted for the majority oflaboratory interferences was cephalosporins at 49.3% (37/75).Specifically, cefoxitin was the most common [16% (12/75) ] antibioticcausing a laboratory interference. The mechanistic reason for thisinterference is the reaction between cephaloporins, especiallycefoxitin, and the chemical alkaline picrate used in the Jaffe reaction,resulting in a falsely high serum creatinine. Other classes of antibioticsassociated with interferences included b-lactams, macrolides, andfluoroquinolones. The laboratory test most frequently affected byantibiotic was serum creatinine. The articles evaluated indicated thesewere actual interferences and not due to cephalosporin inducednephrotoxicity. Other laboratory tests affected by interference includedAST, ALT, serum glucose, and urine catecholamine. CONCLUSION: Antibiotics have been shown to interfere with theresults of a wide variety of commonly used laboratory tests. Healthcare professionals must use discretion when evaluating a patientlaboratory results when a patient is prescribed an antibiotic.

Ambulatory Care

389. Assessing interest in clinical pharmacy services within aunique community setting. Nadine H. Kazem, M.A., Pharm.D.,Candidate, Samantha Karr, Pharm.D., BCPS, Mary K. Gurney, Ph.D.,R.Ph.; Midwestern University College of Pharmacy, Glendale, AZ PURPOSE: There is currently limited data regarding pharmacistsproviding clinical services in community settings beyond ambulatorycare or medication therapy management (MTM) clinics or in retailpharmacy settings. This study was designed to assess communityresidents’ interest in the establishment of an academic ambulatory caresite offering pharmacy clinical services within a unique communitysetting. METHODS: Focus groups representative of participants wereconducted to elicit themes to include within the survey. A descriptivesurvey was constructed and approved by our institution’s IRBCommittee. Survey participants were recruited from two city-fundedcommunity centers; the Foothills Recreation and Aquatics Center, andthe Glendale Public Library. Inclusion criteria included adults,regardless of age, gender, or race. An anonymous 17-question self-administered survey was made accessible to participants by: 1) mail;2) a Qualtrics web-based survey link; and 3) a hard-copy formatavailable at each site. Participants were asked to provide responsesregarding demographic data, current chronic medical conditions,regular use of prescription and over-the-counter (OTC) products, useof home medical devices, and perceived benefit of pharmacist clinicalservices including drug utilization review (DUR), explanation oflaboratory results, and assistance with optimizing use of home medicaldevices. Study participants were also asked to identify interest inadditional individual or group consultation services. It is estimatedthat 100 respondents will be required for final analysis of surveyresults. RESULTS: Data collection and analysis are still in progressand will be completed by September 2011. CONCLUSION: Studyconclusions will be made after final analysis of the data.

390. Identified drug therapy problems in a federally qualifiedhealth center. Riane J. Ghamrawi, Pharm.D., Candidate, Natalie J.Kolehmainen, Pharm.D., Candidate, Eric M. Tuttle, Pharm.D.,Candidate, Magdi H. Awad, Pharm.D.; Northeast Ohio MedicalUniversity, Rootstown, OH PURPOSE: Previous analyses of drug therapy problems (DTP), inmostly insured patient populations, identified “needs additional drugtherapy” as the most common DTP followed by “dosage too low” and“non-adherence.” The purpose of this study is to examine DTPidentified in a federally qualified health center (FQHC). METHODS: Retrospective chart reviews of medication therapymanagement encounters by a pharmacist and pharmacy externsbetween September 2010 and March 2011 was completed. RESULTS: One hundred and forty patient charts were reviewed. Theaverage number of medications and medical conditions per patientwas 10.95 and 8.05, respectively. The average number of DTP was5.16 per patient. Over one third of the patients were uninsured. “Non-adherence” (27.10%), “needs additional drug therapy” (17.03%), and“ineffective drug therapy” (17.00%) were the most DTP identifiedfrom the charts reviewed. About half of the “non-adherence” DTP wascaused by the lack of patient understanding of medication relateddirections. Additionally, over 75% of “ineffective drug therapy” wasattributed to the lack of effectiveness monitoring parameters placed infor specific medications. Out of the 723 DTPs uncovered, 35.5% wereresolved by the pharmacist/pharmacy externs, and 64.45% werereferred to the primary care provider with appropriaterecommendations. CONCLUSION: “Non-adherence” is a more prevalent issue inFQHC. Clinicians in similar settings need to implement effectiveapproaches to communicate appropriate medication use to patients andto monitor efficacy parameters.

391. Patients’ perception of clinical pharmacy services in afederally qualified health center. Natalie J. Kolehmainen, Pharm.D.,Candidate, Riane J. Ghamrawi, Pharm.D., Candidate, Eric M. Tuttle,Pharm.D. Candidate, Magdi H. Awad, Pharm.D.; Northeast OhioMedical University, Rootstown, OH PURPOSE: To determine patients’ perception of medication therapymanagement (MTM) services in a federally qualified health center(FQHC) METHODS: Patient satisfaction questionnaires were available to 140patients who received MTM services by a pharmacist and pharmacyexterns between September 2010 and March 2011. Questionnaire wasdeveloped utilizing previous instruments that surveyed patients’satisfaction and attitudes toward MTM. Questionnaire was reviewedfor face and content validity. RESULTS: Questionnaires will be collected between May–July 2011.Descriptive data of the patients’ perception will be presented.Elements presented will include patients’ satisfaction and attitudestoward expanding the service, perceived impact on medicationutilization and overall health outcomes, and an average of suggestedcharges for the MTM service

392. Utilization of IPADs to facilitate data collection duringpediatric screening events. Amy E. Haver, Pharm.D., Candidate1,Nicole Marcotullio, Pharm.D.2, Jennifer P. Elliott, Pharm.D.1;(1)Duquesne University Mylan School of Pharmacy, Pittsburgh, PA;(2)Duquesne University, Mylan School of Pharmacy, Pittsburgh, PA PURPOSE: To determine whether the use of IPADs versus paperforms during the intake process at screening events will provide a lesstime consuming method of collecting patient information. METHODS: The screening events primarily focus on children ages 5to 17 to determine if they are at risk for asthma, obesity, andhypertension which has been approved by our IRB committee. Prior tothe screening events caregivers are asked to complete seven forms foreach child participating and the children complete five forms. With theuse of the IPADs the above documents were converted to PDF filesand available for viewing through the TakeNotes Application. Throughthe TakeNotes program, the participants can sign forms, circle objects,and write in text boxes on the corresponding documents. Folders arecreated in the TakeNotes Application containing all of the paperworkfor each child and caregiver and synced with notebook computers forstorage and data analysis.


RESULTS: Participants were randomized to complete the intakeprocess via IPAD or paper form. Twenty-eight participants completedthe intake process with sixteen using the IPADs and twelve usingpaper. The average time to complete the forms for the IPADs andpaper was 3 minutes and 36 seconds and 3 minutes and 54 secondsrespectively. Of the twenty eight participants 64% of the children and86% of the caregivers preferred the IPADs for the intake process. Ofthe twelve participants using paper initially 50% indicated that theywould have preferred to use the IPADs. CONCLUSION: This study will provide evidence of a novel methodof data collection that will provide health care professionals with aless time consuming and economically acceptable way of collectingpatient information, while also improving patient satisfaction and theability provide a more mobile method of data collection and transfer.

393. Risk for medication non-adherence and other drug therapyproblems among ambulatory patients in a safety-net health-system. Amanda Skibowski, Pharm.D., Candidate, 20141, Alan J.Zillich, Pharm.D.1, Bradley N. Doebbeling, M.D., M.S.2, Margie E.Snyder, Pharm.D., M.P.H.1; (1)Purdue University College ofPharmacy, West Lafayette, IN; (2)Indiana University School ofMedicine, Indianapolis, IN PURPOSE: To 1) characterize the patient population using a safety-net health system outpatient pharmacy, 2) estimate the prevalence ofdrug therapy problem risk factors, 3) identify patient factorsassociated with a high risk for nonadherence and other drug therapyproblems, and 4) identify patient medication management routines andpharmacist actions as potential strategies for preventing and/orresolving drug therapy problems that should be explored further. METHODS: Data were collected via a survey administered to aconvenience sample of ambulatory patients waiting for prescriptionsat a safety-net pharmacy. Eligible patients were 21 years of age orolder and using at least one prescription medication regularly for achronic condition. Surveys were distributed during various days andtimes. Surveys obtained information regarding participants’demographics, pertinent history for the identification of drug therapyproblem risk factors, self-reported medication adherence, and open-ended responses describing participant medication managementroutines and interactions with pharmacists. Parametric and non-parametric statistics will be used as appropriate to analyze quantitativedata. Qualitative analytic methods will be used to identify themes inmedication management routines and pharmacist interactions. RESULTS: Data collection is ongoing with 17 of a targeted 150surveys completed. Updated results will be presented at the meeting. CONCLUSION: We anticipate that our findings will provide insightinto drug therapy problem risk factors present among medicallyunderserved patients. This work will provide preliminary dataregarding medication management routines and pharmacist actions tobe examined in future investigations. This will inform the design ofmedication therapy management programs and other interventionsintended to prevent, minimize and/or resolve drug therapy problems.

Cardiovascular

394. A comparison of survey methods on vitamin, herbal, andover-the-counter product use in patients with heart failure. AnitaKashyap, Pharm.D., Candidate1, Stuart L. Burke, Pharm.D.,Candidate1, Lucas M. Boehm, Pharm.D., Candidate1, LeahHolschbach, B.S., Pharm.D.2, Tim M. Miller, Pharm.D.1, OrlyVardeny, Pharm.D., M.S.1; (1)University of Wisconsin School ofPharmacy, Madison, WI; (2)Froedtert Hospital, Milwaukee, WI PURPOSE: Over-the-counter (OTC) and herbal product use isincreasing in patients with cardiovascular disease, and may beunderreported. We hypothesize that different survey methods to collectOTC and herbal use, may result in different patient reporting of theseproducts. This study was designed to 1.) assess the frequency of OTCand herbal consumption in heart failure (HF) patients and examinepredisposing factors that may predict usage; and 2.) investigatedifferences in data collected from self-completed versus healthcareprovider administered survey methods. METHODS: One hundred sixty HF patients will be enrolled from theUniversity of Wisconsin Advanced Heart Disease Clinic. Participantswill complete a survey on herbal and OTC product use, reasons and

sources of information for use, and reporting habits to health careproviders. Eighty participants will self-complete the survey, and eightyage-matched participants will be administered the survey bypharmacists or pharmacy students. Medical records will be accessed toidentify HF disease severity factors and current medications. RESULTS: The first 80 participants (53 male, 27 female) were 56 ±15.1 years old. Mean ejection fraction was 36.6 ± 16.5%, and NYHAfunctional classes were I (n=23), II (n=41), III (n=15), and IV (n=1).91% reported using a vitamin, OTC, or herbal product. The mostcommon vitamin, OTC, and herbal used was a multivitamin (45%),aspirin (48.8%), and fish oil (28.8%) respectively. Among users,42.5% reported using a product that was not documented in theirmedical record. Survey results for the next 80 participants andcomparisons with the first 80 participants will be reported. CONCLUSION: Use of non-prescription therapy is prevalent inpatients with HF, and is not always reported to health care providers.These data will give insight on the differences in methods to collectaccurate information from patients who may benefit from educationon safe OTC and herbal use.

395. Inpatient management of warfarin therapy by pharmacistscompared to physicians. Pio Juan Lansangan, B.S.1, Jin-HeeNomura, Pharm.D.2, Teresa Hong, Pharm.D.2, Lynn Ishida-Kitazawa,Pharm.D.2, Sheryl L. Chow, Pharm.D., BCPS3; (1)Western Universityof Health Sciences, Pomona, CA; (2)Centinela Hospital MedicalCenter, Inglewood, CA; (3)Western University of Health Sciences andLA BioMed at Harbor-UCLA, Pomona, CA PURPOSE: Several studies have reported outcomes associated withpharmacist management of newly-initiated warfarin therapy inhospitalized patients. However, fluctuations in therapeutic rangesoften occur in hospitalized patients on stable doses of warfarin therapybecause of acute disease, drug-drug interactions, and changes in diet,requiring proactive anticoagulation management. The purpose of ourstudy is to compare physician vs. pharmacist-directed management inhospitalized patients who are receiving chronic warfarin therapy inaddition to those receiving first-time dosing. METHODS: A total of 220 consecutive hospitalized patientsadmitted to Centinela Hospital Medical Center from January 1, 2010to July 1, 2011 were included in this study. These patients requiredinitiation and/or maintenance of warfarin therapy and were managedby either a physician or pharmacist (110 patients per group). Baselineparameters including drug interactions, indication, and warfarin usebefore admission were documented. The mean internationalnormalized ratio (INR) at discharge and the rate of patients who weresubtherapeutic (INR < 1.5), supratherapeutic (INR > 3.5), orexcessively supratherapeutic (INR > 6.0) were compared betweengroups. The impact of anticoagulation management on patientoutcomes was measured by bleeding rates, length of stay (LOS), anddays to reach therapeutic INR (DTTI). RESULTS: Preliminary data for 63 patients (28 physician-directed,35 pharmacist-directed) has been completed. The mean INR atdischarge was similar between physician and pharmacist-directedmanagement (1.9 vs. 1.8, p=0.41). Both groups demonstrated nodifferences in rates of subtherapeutic, supratherapeutic, andexcessively supratherapeutic INRs. Although a trend towards areduced LOS was observed in patients treated by physicians (5.7 vs.7.2 days, p=0.15), the DTTI was similar between groups (1.5 vs. 1.7days, p=0.77). CONCLUSION: Data from the remaining patients are currentlybeing collected and the completed results and conclusion of all 220patients will be presented.


396. Analysis of wait time disparities in the emergency departmentfor patients reporting with a chief complaint of chest pain from2003 to 2008. Melissa Buchanan, B.S., Tina Tseng, Ph.D., M.S.P.H.;Campbell University College of Pharmacy & Health Sciences, BuiesCreek, NC PURPOSE: The purpose of this study was to evaluate disparities inchest pain complaining patients’ characteristics (age, sex, race, andpayment type) and wait time to see a physician in the emergencydepartment (ED).

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METHODS: The National Hospital Ambulatory Medical Care Survey– Emergency Department (NHAMCS-ED) database from 2003 to2008 was utilized for a retrospective cross-sectional study. Patients 30years and older, received an ECG, and listed chest pain as the primaryreason for visit were included in the study. The endpoint used for allstatistical analyses was wait time to see a physician. T-test analyseswere performed to assess if there was a difference in wait timeregarding age, sex, race, and payment type. A subset analysis wasperformed with significant data from previous T-test analyses toexamine if a difference in wait times persisted for patients triaged asemergent. RESULTS: There were 5,540 patients included in the analysissample. Only 27% of patients were seen by a provider within theACC/AHA guidelines recommended timeframe of 10 minutes.Patients that were 65 years and older (p<0.001), Caucasian (p<0.001),and had Medicare insurance (p<0.001) had shorter wait times to see amedical care provider. In the subset analysis of emergent chest paincomplaining patients, both older (p<0.001) and Caucasian (p<0.001)patients had shorter wait times. CONCLUSION: The majority of patients were not seen in therecommended guidelines of 10 minutes. Disparities in wait time to seea provider were observed with age and race. Older, Caucasian patientscomplaining of chest pain were seen in a shorter amount of time;however, they were still not seen within the suggested 10 minutes.Additional studies need to be done to further understand the etiologyof these disparities and determine how incorporating a pharmacist inthe ED can decrease disparities and increase patient care.

397. A mentoring program for clinical and operation supervisors.Kayley M. Lyons, Pharm.D., Student1, Steve Bohn, R.Ph.2, AnnNadrash, Pharm.D., BCPS2; (1)South Dakota State University Collegeof Pharmacy, Sioux Falls, SD; (2)Kaiser Permanente ColoradoRegion, Aurora, CO PURPOSE: This study provides a description of a formalizedmentoring program for operational and clinical pharmacy supervisors.The goal of the program is to foster collaboration and accelerate thesupervisors’ leadership development through valuable mentoringrelationships. METHODS: This program was implemented in the pharmacydepartment at Kaiser Permanente Colorado (KPCO). Entry levelsupervisors were matched with both a clinical and operationsupervisor with demonstrated success. The program included atraining presentation, supervisor self assessment at baseline and every3 months, supervisor assessment from the mentor every 3 months, anintroduction meeting, continuous meetings, and a program evaluationfrom both an online survey and telephone conversations with programdirectors. The program is a year in length, with a rotation of mentorsafter six months.

398. Developing a Sentri7®-driven inpatient clinical pharmacyservice. Jennifer Popa, Pharm.D., Candidate, Andrew P. Smith,Pharm.D., Candidate, Christina J. Dewar, Pharm.D., BCPS; AultmanHospital Inpatient Pharmacy, Canton, OH PURPOSE: Sentri7® is one of several patient surveillance softwareprograms available to assist pharmacists providing clinical pharmacyservices. This study evaluated the impact and effectiveness of usingSentri7® surveillance software to provide clinical pharmacy servicesto hospitalist patients on a step-down unit compared to servicesprovided by a clinical pharmacist. METHODS: A prospective observational study was conducted overan 8-week period. Reports generated from a clinical pharmacist andfrom Sentri7® were used to present pharmacy interventions to ahospitalist. Time taken to generate the reports, number of patients,number of interventions, type of interventions and physician responseswere tracked. RESULTS: The first ten days of data collection have been completed.An interim total of 98 patients were seen generating 112 clinicalpharmacist interventions in 21 categories and 122 Sentri7®interventions in 16 categories. Many, but not all of the interventionswere recommended by both the clinical pharmacist and Sentri7®. Theinterim average time spent by the clinical pharmacist was six minutesper patient. The interim average time spent using Sentri7® was twominutes per patient. Data collection is expected to be completed in

August, 2011 with final results to include the above analyses as wellas an average of the physician acceptance rates of interventions overalland in each category. CONCLUSION: Interim data shows that pre-rounding with Sentri7®takes roughly one-third of the time taken by a clinical pharmacist andstill provides basic clinical pharmacy coverage. The time saved couldallow the pharmacist to perform a wider range of tasks or providemore in-depth clinical services. It is expected that the analysis ofphysician acceptance rates will reveal that the clinical pharmacistmakes more comprehensive recommendations but both Sentri7® andthe clinical pharmacist catch basic pharmacy issues with highphysician acceptance rates.


399. Improving health outcomes and continuity of care inunderserved, urban populations. Katie Park, Pharm.D., Candidate,Jamie L. McConaha, Pharm.D.; Duquesne University Mylan Schoolof Pharmacy, Pittsburgh, PA PURPOSE: Heart disease is the leading killer across most ethnicminority communities in the United States, and causes the death of50% of people with diabetes (IDF 2010). Both disease states can beeffectively managed with early detection and monitoring. Limitedaccess to health care results in undiagnosed and mistreated disease dueto a lack of continuity of care. The purpose of this study is to measurethe impact of pharmacist intervention, by free health screenings andpatient education, on improving health outcomes and continuity ofcare in underserved, urban populations. METHODS: Utilizing a grant through the Pennsylvania Departmentof Health, three free health screenings providing blood pressure,cholesterol, blood glucose, and body mass index screenings were heldat underserved community pharmacy locations. Patient health historywas input into an electronic database. Patients were then counseled bya pharmacist on medication and lifestyle changes and receivededucational supplemental materials. A process existed to enroll anyhigh-risk patients into the Duquesne University Medication TherapyManagement (DM2) program, which provides free medication therapymanagement sessions and has a collaborating physician available. Sixmonths after the screening events, follow-up phone calls will be madeto assess any changes in patient lifestyle, medications, or diseaseprogression. Specifically, a questionnaire will be administered toevaluate changes in health status markers, new or modifiedmedications, and improvements in lifestyle. RESULTS: A total of 50 patients participated and were enrolled in thestudy. Patient demographics revealed a mean age of 58 years, with58% being female. Study protocol calls for follow-up interviews to beconducted six months post-screening (July 2011) to assess if anychanges have occurred to the pre-established success of the project.Results will be presented at the ACCP Annual Meeting in October. CONCLUSION: Pharmacist-provided free health screenings andinterventions will positively impact health outcomes of underservedpatient populations.

400. Financial impact of a community pharmacy basedanticoagulation service. Nicholas P. Mariani; Wayne StateUniversity, Tecumseh, ON, Canada PURPOSE: There is little published data on the financial impact ofproviding clinical pharmacy services in the community pharmacysetting. The purpose of this study is to analyze and define theeconomics of a community-pharmacy based anticoagulation service. METHODS: Prescription and clinical records for all patients referredto Novacare Pharmacy’s Anticoagulation Service from October 2009to July 2011 will be comprehensively collected. Total revenue perpatient will be calculated which will encompass all clinical billingsand drug costs. Data will also be collected on pharmacist time,technician time, equipment costs and overhead cost in order tocalculate the expenses to provide the anticoagulation services. Basedon the data collected, three economic models will be created in orderto assess the feasibility of this type of service in various pharmacysettings. These models will assess: 1) gross profit per patient based onclinical billings solely 2) prescription revenue per patient (excludingclinical billings) 3) total revenue per patient in addition to estimatedgross profit per patient. Data will be collected and analyzed by the


presentation date.

Critical Care

401. Assessing an institution-specific therapeutic hypothermiaprotocol: outcomes and associated adverse events. Sara Varnado,Pharm.D., candidate, Lam Nguyen, Pharm.D., Robert MacLaren,Pharm.D.; University of Colorado School of Pharmacy, Aurora, CO PURPOSE: To assess an institution-specific hypothermia protocol interms of patient outcomes and the occurrence of hypothermia-relatedadverse events. METHODS: A single center, retrospective chart audit was performedon 42 patients who received therapeutic hypothermia for ≥6 hours.Cerebral performance categories (CPC) scores were applied todelineate patients with neurologic recovery (CPC of 1-3) and poorneurologic outcomes (CPC of 4 or 5). These groups were comparedusing univariate analyses. Descriptive and repeated measures statisticscharacterized electrolyte, glucose, and coagulation parameters and theoccurrence of shivering over time. RESULTS: Twenty (47.6%) patients demonstrated neurologicrecovery. Patient demographics were similar between groups with 29(69.1%) males and an overall age of 52.5±15.9 years. Initial cardiacrhythm, documented time down, and the time to initiate hypothermiawere similar between groups. Patients with neurologic recovery tooklonger to achieve hypothermic goal (5.7±2.4 hours vs. 4.2±2 hours,p=0.03) but spent longer at goal temperature (16.9±4.2 hours vs.12.8±6.2 hours, p=0.031). Patients with neurologic recovery were lesslikely to require dobutamine (10% vs. 40.9%, p=0.06), epinephrine(20% vs. 54.6%, p=0.06), or norepinephrine (25% vs. 63.6%, p=0.04)infusions despite bradycardia being more common (81.8% vs. 36.4%,p=0.01). Neurologic recovery was associated with being dischargedalive (95% vs. 5%, p<0.001). During hypothermia,hyperphosphatemia and hyperglycemia were more common in patientswith poor neurologic recovery. Overall, 37 (88.1%), 35 (83.3%), 22(52.3%), and 28 (66.7%) patients required supplementation withpotassium, magnesium, phosphate, and insulin, respectively.Coagulation parameters during hypothermia varied minimally frombaseline. All but three patients required neuromuscular blockade forshivering. CONCLUSION: Patients with neurologic recovery differ from thosewith poor neurologic outcomes. Additional patient charts will beaudited and multivariate analyses applied to determine predictors ofrecovery. The clinical application of therapeutic hypothermia isassociated with electrolyte disturbances, hyperglycemia, bradycardia,and shivering; frequently necessitating therapeutic interventions.

402. Observational study of dexmedetomidine in trauma criticalcare patients. Kristina Rokas, Pharm.D., Candidate1, April D. Miller,Pharm.D., BCPS1, Brianne L. Dunn, Pharm.D.1, Christopher Watson,M.D.2; (1)South Carolina College of Pharmacy-USC, Columbia, SC;(2)Palmetto Health Richland, Columbia, SC PURPOSE: Dexmedetomidine is an alpha-agonist that providessedation, anxiolysis, and analgesia without respiratory depression.These properties are beneficial in critically ill trauma patients whofrequently require large doses of sedative agents and are being weanedfrom mechanical ventilation. There are few data on dexmedetomidinein a trauma intensive care unit (ICU) setting, and this study aims toevaluate the safety and efficacy of dexmedetomidine in thispopulation.METHODS: Patients admitted to the Trauma ICU without traumaticbrain injury who received dexmedetomidine for ≥ 12 hours wereincluded in the study. Medical records were reviewed to evaluate theefficacy of dexmedetomidine at producing desired sedation levels onthe Richmond Agitation and Sedation Scale (RASS), doses used, andadverse events, including bradycardia (HR<60bpm) and hypotension(BP<90/60 mmHg). RESULTS: Twenty patients met inclusion criteria, withapproximately half of patients presenting with injuries to the chest orabdomen. Seven patients (35%) were female with an average age of39.5 years old. Pertinent comorbidities were minimal with theexception of two patients with a history of cirrhosis and one patientwith hepatitis C. Average length of stay and duration of mechanicalventilation was 18.3 days and 13.3 days, respectively. The marginal

mean dosage received was 0.8 µg/kg/hour, and 10 patients receivedmean doses ≥ 0.7 µg/kg/hour, the maximum manufacturerrecommended dose. Dexmedetomidine was administered for a medianof 68.5 hours (range 20 to 261 hours). Most RASS scores (73.6%,131/178 scores) were in the desired sedation range (-2 to 1). Therewere a total of 86 episodes of bradycardia in 6 patients. Hypotensionoccurred in 17 patients, with only one patient requiring treatment.CONCLUSIONS: These results suggest that trauma ICU patientsreceive high doses of dexmedetomidine, spend a majority of time inthe desired sedation range, and have minimal drug-related episodes ofsignificant bradycardia or hypotension.

403. A multi-center characterization of antipsychotic use for thetreatment of delirium in medical ICU patients. Allison Meyer,Pharm.D., Candidate1, April D. Miller, Pharm.D., BCPS1, Emily K.Dornblaser, Pharm.D., BCPS2, Cassandra J. Bellamy, Pharm.D.,BCPS3, William D. Schweickert, M.D.3, Amanda M. Ball, Pharm.D.,BCPS3; (1)South Carolina College of Pharmacy - USC Campus,Columbia, SC; (2)University of New England, Portland, ME;(3)Hospital of the University of Pennsylvania, Philadelphia, PA PURPOSE: The estimated incidence of delirium in ICU patients hasbeen reported to be as high as 80% in some studies. The occurrence ofdelirium in critical illness has been associated with several negativeoutcomes including increased mortality. Although the data are notrobust, the clinical use of atypical antipsychotics (AA) for ICUdelirium has become an accepted practice at many institutions. Theobjective of this study is to characterize the use of atypicalantipsychotics and haloperidol for the treatment of delirium in medicalICU (MICU) patients. METHODS: MICU patients receiving an antipsychotic betweenJanuary 2006 and January 2010 at two academic institutions wereselected for study inclusion. Retrospective review was performed andindications for antipsychotic use, dosing, risk factors for delirium, andbenzodiazepine and opioid use were recorded. Since QTc intervalprolongation can be a side effect of antipsychotics, QTc intervals werealso collected. RESULTS: Of 172 patients screened, 101 met inclusion criteria. Theaverage age was 57.3 years. Thirty-seven patients had renaldysfunction (serum creatinine > 1.5 mg/dL) and 7 had hepaticdysfunction (AST and/or ALT > 2 times the upper limit of normal).Twenty-nine patients (45%) received an AA for a baseline psychiatricdisorder, with the remainder receiving agents for agitation/anxiety(14%) or undocumented reasons (42%). Haloperidol (54%),risperidone (25%) and quietiapine (24%) were the most frequentlyprescribed antipsychotic medications. Risperidone was the mostfrequently prescribed AA at one site (47%), while quetiapine was mostcommon at the other (50%). Of the 81 patients with baseline EKG’spresent, 48 patients (59%) had QTc intervals > 450 mseconds.Twenty-four patients (44%) with prolonged QTc intervals receivedhaloperidol. CONCLUSION: Atypical antipsychotics are used frequently for pre-existing psychiatric conditions. The choice of AA was most oftenbased on continuation of home medication. Haloperidol was primarilyused for ICU delirium.

404. Hemodynamic targets and vasopressor use in neurogenicshock. Maryjoy R. Lepak, Pharm.D., Candidate1, April D. Miller,Pharm.D., BCPS1, Kimberly B. Clark, Pharm.D., BCPS2; (1)SouthCarolina College of Pharmacy-USC Campus, Columbia, SC;(2)Greenville Hospital System University Medical Center, Greenville,SC PURPOSE: Hemodynamic management in patients with acute spinalcord injury (SCI) and neurogenic shock can improve outcomes. Thepurpose of this study is to determine which specific vasopressors aremore effective at maintaining blood pressure in SCI with neurogenicshock, and whether certain agents improve outcomes. METHODS: This multicenter, retrospective, observational studyincluded adult patients with cervical or thoracic SCI and neurogenicshock. Two vasopressors, dopamine and phenylephrine, werecompared based on blood pressure maintenance within target ranges,dosage adjustments, duration of therapy, heart rate, and outcomesbased on the American Spinal Injury Association (ASIA) scale. RESULTS: Preliminary results include evaluation of 12 patients (5

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phenylephrine, 4 dopamine¸ and 3 combination therapy). Mean doseof phenylephrine was 0.94 µg/kg/min (range 0.30–1.58). Mean dose ofdopamine was 5 µg/kg/min (range 2–9). Average number of doseadjustments per hour was similar, with 0.35 per hour withphenylephrine and 0.36 per hour with dopamine. Average duration oftherapy for phenylephrine was 47 hours versus 38 hours for dopamine.Average mean arterial pressure (MAP) for phenylephrine was 81mmHg (range 61–102) versus 73 mmHg (range 59–96) for dopamine.There were a similar number of systolic blood pressure readings≥90mmHg (86% of phenylephrine versus 84% of dopamine). Therewere 57 episodes of tachycardia (HR>100) in 5 patients who receivedphenylephrine relative to 14 episodes in 4 patients who receiveddopamine. There were no differences in outcome among 7 patientswith recorded ASIA scores. Complete impairment (ASIA score A) wasobserved in 2 phenylephrine, 1 dopamine, and 2 combination therapypatients, while incomplete impairment (ASIA score B) was observedin 1 phenylephrine and 1 dopamine patient. CONCLUSION: In this preliminary analysis, phenylephrine wasassociated with a longer duration of therapy and more tachycardia, butmaintained higher MAP in patients with neurogenic shock. In thissmall study, ASIA outcomes appear similar between groups.

405. A retrospective cohort study on the use of dexmedetomidinein patients with traumatic brain injury. Jacquelyn E. Bryant,Pharm.D., Candidate1, April D. Miller, Pharm.D., BCPS1, Brianne L.Dunn, Pharm.D.1, Christopher M. Watson, M.D.2; (1)South CarolinaCollege of Pharmacy - USC, Columbia, SC; (2)Palmetto HealthRichland, Columbia, SC PURPOSE: Dexmedetomidine is known for its unique sedativeproperties in critically ill patients however, its effects in patients withtraumatic brain injury (TBI) are not well studied. This study wasdesigned to characterize the safety and efficacy of dexmedetomidineuse in TBI patients. METHODS: Retrospective review of medical records for patientswho received dexmedetomidine at our institution between December1, 2008 and December 31, 2010 was conducted. Patients included inthe study were adults with non-penetrating TBI and no past medicalhistory related to any neurologic illness or impairment. RichmondAgitation Sedation Scale (RASS) score, Glasgow Coma Scale (GCS)score, heart rate, mean arterial pressure (MAP), intracranial pressure(ICP), and dexmedetomidine dose were recorded. RESULTS: For the 27 patients included in the study, mean age was41 years, and 24 patients were male. The average dexmedetomidinedose administered was 0.65 µg/kg/hour. Median admission GCS scorewas 6 with 51.9% of patients classified as minor brain injury, 14.8%as moderate, and 33.3% as severe. RASS scores were generally withintarget range with 276 of the 402 (68.7%) scores assessed between -2to +1. Fifteen patients experienced 110 total episodes of bradycardia(< 60 beats per minute), and 21 patients experienced 300 totalepisodes of tachycardia (> 110 beats per minute). Twelve patients hada total of 17 MAP readings < 60 mmHg. ICP was monitored in twopatients, both of which were controlled (ICP<20 mmHg). CONCLUSION: Overall, the use of dexmedetomidine in this studypopulation proved to be safe and efficacious. Episodes of bradycardiaoccurred less often than previously observed. Based on the limitedICP data, dexmedetomidine did not appear to adversely affect ICP inthis study population.

Education/Training

406. Evaluation of an interprofessional approach to teachingmedication therapy management (MTM).Jaclyn A. Kruse, B.S., M.S., Pharm.D., Candidate1, Zachary N.Jenkins, Pharm.D., Candidate2, Austin Fredrickson, M.D., Candidate3,Timothy R. Ulbrich, Pharm.D.3, Stacey R. Schneider, Pharm.D.3;(1)Northeast Ohio Medical University, Willowick, OH; (2)NortheastOhio Medical University, Akron, OH; (3)Northeast Ohio MedicalUniversity, OH PURPOSE: This study evaluated the impact of an interprofessionalapproach to teaching Medication Therapy Management (MTM) on 1)the student’s understanding of MTM and its place in patient care; 2)the ability of students to participate in an MTM session; 3) thedifference in awareness, knowledge, and opinion of MTM before and

after the training session; and 4) the student’s perception ofcollaborating with other healthcare professionals to provide MTM. METHODS: Pharmacy and medical students at Northeast OhioMedical University were invited to voluntarily participate in twointerprofessional sessions to learn about MTM. Session one involved apre-survey, educational seminar, and a practice MTM case. Sessiontwo consisted of a mock MTM session with volunteer patients,followed by a post-survey. RESULTS: The pre-survey included 23 student responses; 7 medicaland 16 pharmacy. Fourteen participants had previous exposure toMTM. Ten pharmacy students stated that MTM is a formal part oftheir curriculum. The post-survey included 10 student responses; 3medical and 7 pharmacy. All students “agreed” or “strongly agreed”that optimal MTM takes place when collaboration between multiplehealthcare providers occurs. Lastly, all students noted that they wouldrecommend or participate in an MTM session in the future. CONCLUSIONS: Overall, utilizing an interprofessional approach toteaching MTM was received positively. Students gained experience bycollaborating in mock MTM sessions. Despite the small studypopulation, this study supported integrating MTM into the didacticcurriculum at an interprofessional institution and also providedevidence to support teaching students to work in an interprofessionalteam at an early stage of their careers.

407. Assessing older adults’ knowledge of safe medication use andpractices. Samantha M. Boudreau, Pharm.D., Candidate, 2013, HelenPervanas, Pharm.D.; Massachusetts College of Pharmacy and HealthSciences - Worcester/Manchester, Worcester, MA PURPOSE: This study aimed to 1) assess the knowledge of olderadults regarding the safe use of medications, and 2) examine whethertheir knowledge of safe medication practices improved following astudent pharmacist presentation. METHODS: Study participants at three adult senior centers located inthe Southern New Hampshire area attended an educationalpresentation on the safe use of medications given by a studentpharmacist. The American Association of Retired Persons’ (AARP)“Wise up on Meds” program was used as a teaching tool and wassupplemented by the student pharmacist’s presentation. Participantswere asked to complete a pre and post-survey which includedquestions regarding proper medication disposal, medicationinformation to share with doctors/pharmacists, and the importance ofconsulting a pharmacist before taking over-the-counter (OTC)medications. This research was approved by the Institutional ReviewBoard. RESULTS: A majority of participants were Caucasian (97%) andfemale (93%) between the ages of 71 and 80 (41%). Participantsreported that they took 5 to 7 prescription medications daily (38%),and 2 to 4 OTC medications daily (53%). When asked about theproper way of disposing expired medications 57% of participantschose the correct method of disposal and 31% reported that theyflushed medications down the toilet. Following the presentation, 81%of participants selected the appropriate disposal method. Prior to thepresentation, 76% reported that they informed their doctor/pharmacistabout all medications including vitamins and herbal supplementsversus 88% after the presentation. Additionally, when questionedabout the importance of consulting a pharmacist regarding OTCmedication use, 89% and 96% agreed it was important before andafter the presentation respectively. CONCLUSION: The student pharmacist presentation improvedparticipant knowledge in key areas including proper medicationdisposal, important information to share with pharmacists/physicians,and the importance of consulting a pharmacist regarding the use ofOTC medications.

408. Assessment of student pharmacist learning from amultidisciplinary older adult home visit. Teresa M. Breslin,Pharm.D. Candidate1, Alexander J. Kulik, III, Pharm.D. Candidate1,Carol A. Bugalski Stutrud, B.S.1, Cassandra J. Bowers, Ph.D.2,Geralynn B. Smith, M.S.1, Jennifer Mendez, Ph.D.3, Nelia M. Afonso,M.D.4, Cheryl C. Waites, Ed.D.2, Mary Beth O’Connell, Pharm.D.1;(1)Wayne State University, Eugene Applebaum College of Pharmacyand Health Sciences, Detroit, MI; (2)Wayne State University, Collegeof Social Work, Detroit, MI; (3)Wayne State University, School of


Medicine, Detroit, MI; (4)Oakland University William BeaumontSchool of Medicine, Rochester, MI PURPOSE: To assess achievement of pharmacy experiential goalsdesigned to enhance student learning related to aging, socialconstructs, patient assessment, physician roles, team care, and homevisits from a multidisciplinary team experience with older adults intheir homes. METHODS: 83 pairs of a third-year student pharmacist and second-year medical student assessed an older adult in his/her home. Studentpharmacists performed a comprehensive medication review, identifieddrug-related problems, and with a pharmacy preceptor created arecommendation letter and medication calendar, which were given tothe older adult. Medical students assessed fall risk and activities ofdaily living. Student pharmacists completed a post-visit learningsurvey related to curricular goals. Survey questions were analyzedutilizing descriptive statistics (SPSS v19). Open-ended questions wereanalyzed using qualitative research techniques, resulting in learningthemes. RESULTS: Sixty-six percent of students reported increasedunderstanding about social influences on medication use. Studentsthought (> 70% responses) team care was more comprehensive, couldimprove patient outcomes, and would be important to theirprofessional success. Most students (96%) believed the home visitresulted in additional information that could improve health caredelivery. Based on qualitative findings, students learned that olderadults were more active, independent, and knowledgeable about theirhealth than expected. They felt the medical students were empathetictoward the older adult and demonstrated positive personality traits,professionalism, and good interviewing skills. Students describedmultidisciplinary team care as important and provider rolescomplementary. The home visits were noted to provide anenvironment more comfortable for the older adult as they were quiteamiable, communicative, and receptive to information provided by theteam. Most students (86%) indicated the project was worthwhile andwould recommend it to other students. CONCLUSION: Multidisciplinary training with older adults in ahome environment was a good learning opportunity for the students.

409. North Carolina pharmacists’ practices and opinions ofsmoking cessation counseling. Janna L. Currie, Pharm.D./MSCRCandidate, Nathan J. Hudson, Pharm.D./MSCR, Candidate, Wesley D.Rich, Ph.D.; Campbell University College of Pharmacy and HealthSciences, Buies Creek, NC PURPOSE: Every year, there are over 5 million deaths in the worlddue to cigarettes. In 2009, according to the Centers for Disease Controland Prevention (CDC), one in every five Americans smokes cigarettes.Of the 46.6 million people who smoke in America, 32.6 million wouldprefer to quit but have not been able to quit smoking. Health careprofessionals, including pharmacists are in a position to help thoseindividuals quit. In order to begin this process, barriers to counselingneed to be identified, as well as current habits and pharmacists’opinions on smoking cessation in general. METHODS: A survey was sent out to all registered North Carolinapharmacists regarding smoking cessation counseling practices andopinions on tobacco sales in pharmacies. Specifically, pharmacistswere asked about comfort levels with smoking cessation, opinions onthe role of the pharmacist in the process, and what barriers preventthem from discussing smoking habits with patients. Additionallydemographic information was gathered regarding pharmacy settingand potential ethical considerations for selling tobacco products inpharmacies. Other questions revolved around the 5 A’s of smokingcessation: ask, advise, assess, assist, and arrange. RESULTS: Results are pending. CONCLUSION: The results of this survey will provide informationabout the next step for pharmacists in the role of smoking cessation.Knowing what barriers are present and how pharmacists currentlypractice may justify the need for pharmacist-facilitated smokingcessation programs or other methods of helping patients quit smoking.

410. Experiential value of an older adult medication assessmentearly in the pharmacy curriculum. Kimberly M. Rutkowski,Pharm.D. Student, Kirsten M. Freitel, Pharm.D. Student, Tara C.Rosenthal, Pharm.D. Student, Geralynn B. Smith, M.S., Mary Beth

O’Connell, Pharm.D.; Wayne State University, Eugene ApplebaumCollege of Pharmacy and Health Sciences, Detroit, MI PURPOSE: To evaluate the learning and appropriateness of an olderadult medication review early in the curriculum. METHODS: Older adults visited the college to meet first-yearstudents who would soon provide their medication review with apharmacist. The team performed the review at the older adult’sindependent living residence during spring/summer year oneexperiential courses (IPPE). The pharmacist gave each older adult amedication calendar and list of recommendations. Three months later,the students visited their older adult to learn about recommendationimplementation. After each aspect, students wrote a reflection.Students completed an anonymous learning survey after the program(39% response). Descriptive statistics (SPSS v19) were used tosummarize survey data and qualitative research techniques (Atlas.tiv6.2) were used to determine learning themes from the reflections. RESULTS: Students (≥73%) felt comfortable speaking with olderadults at the social event, were confident in their duties, and thoughtthe follow-up visit was valuable. They felt the medication review wasbeneficial to the older adult (70%). This experience helped developcommunications skills (60%), enhanced understanding of pharmacists’roles in medication management (70%), and expanded medicationknowledge (57%). Students thought this project should be continued(57%) and recommended changes. In the reflections, studentsdescribed learning about older adult lifestyles, health, and medicationissues. Students were able to practice and improve skills gainedthroughout didactic and lab courses (e.g., self-confidence, older adultinterviewing). They learned how to prepare a medication calendar.Many students felt the older adults also benefited from the interaction.Drug related problems were identified and resolved throughout theproject that might not have been recognized otherwise. Reflectionreviews from the social event and 3 month follow-up visit arepending. CONCLUSION: Students learned about older adult lifestyles,medication issues and assessment adjustments. The experience will becontinued in the curriculum with changes.

411. Building a curriculum to combat obesity in elementaryschools. Chelsea M. Harrison, Pharm.D. Candidate, Elizabeth J.Bunk, Pharm.D. Candidate, Ashley D. Modany, Pharm.D. Candidate,Jennifer P. Elliott, Pharm.D., Nicole Marcotullio, Pharm.D.; DuquesneUniversity Mylan School of Pharmacy, Pittsburgh, PA PURPOSE: The prevalence of obesity has more than tripled inchildren and adolescents from 1980 to 2008, with 12.5 millionoverweight children in the United States. Children that remain obeseas they enter their teenage years have a 70% greater risk of becomingan obese adult. Currently, there are no universally accepted practiceguidelines for the prevention of childhood obesity. The goal of thisproject is to develop an education curriculum that can be utilized inelementary schools to prevent and reduce the rate of childhoodobesity, and improve childhood awareness of healthy eating habits andbehaviors. METHODS: A literature search was performed through Medline andthe Internet to analyze the currently available childhood obesityprevention programs. Forty programs were identified with tenprograms, the updated United States Department of Agriculture(USDA) nutrition guidelines and the American Academy of PediatricsBright Futures Nutrition 3rd edition chosen for further review. Selectactivities from these resources were adapted to develop thecomprehensive educational curriculum. RESULTS: The program is divided into three main categories:nutrition, physical activity, and healthy behaviors. These weredetermined to be the three most important subjects identified from thechosen resources. Each lesson is designed to incorporate active-learning strategies into 30-minute sessions to effectively engage andeducate elementary school children on childhood obesity prevention. CONCLUSION: Based on the design of the educational model, ourgoal is that this program can be employed in any elementary schoolcurriculum at minimal cost. It will be piloted in an inner cityelementary school in Pittsburgh, PA in January 2012. Theeffectiveness of this educational intervention will be assessed throughthe use of a pre and post knowledge test.

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412. Impact of community pharmacy experience in a familymedicine residency. Sarah E. Krahe Dombrowski, B.S.1, RobertaFarrah, Pharm.D., BCPS2, Stephanie Harriman McGrath, Pharm.D.3;(1)Univeristy of Pittsburgh School of Pharmacy, Pittsburgh, PA;(2)UPMC St. Margaret Hospital, Pittsburgh, PA; (3)Rite AidPharmacy, Pittsburgh, PA PURPOSE: Current literature confirms that patient outcomes improvewhen pharmacy education is included in family medicine residencyprograms, but there has been little research to examine the directimpact of this education on the residents. We plan to evaluate thevalue of a hands-on community pharmacy experience for familymedicine residents with the intent to create a model from whichinterprofesional education can be developed, ultimately enhancingcollaborative relationships among health care providers. METHODS: Through surveys and semi-structured interviews, wewill assess the family medicine residents’ perception of the role of thepharmacist in MTM, OTC medications, and prescription dispensingbefore and after a practical hands-on experience in a communitypharmacy. This data will undergo qualitative analysis to identifythemes and trends in the responses. RESULTS: We plan to report the impact of the pharmacy experienceon the family medicine residents. We expect that the residents willdisplay increased knowledge of OTC medication use and safety.Additionally, we anticipate that they expand their understanding of thebenefit of medication therapy management for their patients and therole pharmacists can play in patient care. Finally, it is expected thatthis experience will increase residents’ enthusiasm for workingcollaboratively with pharmacists. CONCLUSIONS: We plan to use this data to share our methods forfostering interprofessionalism and demonstrate the value ofpharmacist collaboration in a family medicine residency program.This collaborative education program between family medicine andcommunity pharmacists is unique; studying and documenting theimpact of this program will lead to the development ofinterprofessional education in other residency programs.

413. Impact of a student-implemented patient educationcampaign. Alexa M. Sevin, Pharm.D. Candidate, Marshall D.Stewart, Pharm.D. Candidate, Kyle Hampson, Pharm.D. Candidate,Pamela H. Koerner, B.S., Pharm.D., Jennifer P. Elliot, Pharm.D.;Duquesne University, Pittsburgh, PA PURPOSE: This study was designed to encourage studentpharmacists and pharmacists alike to increase the frequency ofproviding education to patients through the use of an “EducationBefore Medication” campaign. This study documented each patientinteraction to learn more about patient perceptions of engaging inmedication counseling as well as feasibility of implementation invarious community practice settings. METHODS: Student pharmacists on Advanced Pharmacy PracticeExperience (APPE) rotations at community sites between February 7and March 11, 2011 were given a standardized “Education BeforeMedication” toolkit that included basic counseling points on seven ofthe most commonly prescribed medications. Students implemented the“Education Before Medication” campaign through a variety of sitespecific methods. Each patient encounter was documented, whichincluded the patient response, medication counseled, and the timespent counseling. RESULTS: Students offered medication counseling to 314 patientstaking one or more of the medications included in the campaigntoolkit. Of these patients, 27.4% refused counseling resulting in 228patients receiving medication counseling through this campaign. Ofthose patients who did accept counseling, 92 were described asattentively listening and another 50 patients asked additional questionsof their student pharmacist. CONCLUSIONS: Through the use of a standardized counselingformat, student pharmacists and pharmacists are able to provide timelymedication counseling in a variety of community practice settings.This campaign is a great resource for any community practice settingas it can be implemented in numerous ways to fit the needs of eachpharmacy. This campaign is also beneficial for student pharmacists, asthey have the opportunity to learn about the medications and practicepatient interaction skills.

414. Becoming an author during your residency: pharmacyresident publication rates and trends (2005–2010). Ashley H. Cribb,Pharm.D. Student, Kalen B. Manasco, Pharm.D., BCPS, AE-C;University of Georgia College of Pharmacy, Augusta, GA PURPOSE: With over 3600 pharmacists applying for PGY1 andPGY2 residencies in 2011, it is clear that post-graduate residencytraining is quickly becoming the new standard of pharmacy education.During the year(s) spent as a resident, pharmacists are often providedthe opportunity to serve as an author for publication in a peer-reviewed journal. The first objective of this study is to review thesuccess rate for pharmacy resident publication beyond the scope of therequired residency research project. The second goal is to establishresidency publication rates specifically in pharmacy journals. METHODS: Data is currently being collected via two methods.Journal reviews of Annals of Pharmacotherapy, American Journal ofHealth-Systems Pharmacists, and Pharmacotherapy, among others,are being conducted to search for publications by PGY1 and PGY2residents during their residency year(s). Specifically, all journal issuesfrom 2005 and 2010 are being reviewed. An electronic questionnairewill also be sent to all Residency Program Directors listed in theonline ASHP residency directory asking for each program’s residentpublications over the years 2005–2010. Program Directors will beasked to provide information regarding both resident research projectsas well as any other articles published during the residency year(s).Data is being collected on type of publication (research, letter to theeditor, case report, etc.), year of publication (PGY1 or PGY2), andorder of authorship (first, second, third). RESULTS: Data analysis is currently pending and will be completedby September 2011 CONCLUSION: Conclusions will be available after data collection iscomplete

415. Gender disparities in authorship of original researchpublications in pharmacy journals. Sloan M. Regen, Pharm.D.Candidate1, Susannah E. Moroney, Pharm.D., M.S.2, Katie J. Suda,Pharm.D., M.S.1; (1)University of Tennessee Health Science Center,College of Pharmacy, Memphis, TN; (2)Pfizer Global Medical,Madison, WI PURPOSE: In 2006, an article published in the suggested that womenphysicians have narrowed the gender gap in serving as either the firstor senior author in medical journals. Since the American Associationof Colleges of Pharmacy statistics suggest that females enrolling inPharm.D. programs has ranged from 50–60% greater than maleenrollment from 2000-2009, we question if increasing number ofwomen pharmacists are contributing to the published pharmacyliterature in the form of original research articles and editorials. METHODS: The sex of first and senior authors of all originalresearch articles and editorials for the years 1995, 2000, 2005, and2010 were evaluated for five pharmacy journals; , , , , and . c2 analyseswere used to compare the frequency of male and female authors in1995, 2000, 2005, and 2010. A p-value less than 0.05 was consideredstatistically significant. RESULTS: There were 384 original research articles and editorialspublished in 1995 compared with 438 articles in 2000, 581 articles in2005, and 578 articles in 2010. Forty-five percent of the first authorswere female in 1995 compared with 44.5% in 2000, 46.8% in 2005,and 47.5% in 2010. In 1995, 32.5% of senior authors were femalecompared with 32.8% in 2000, 32.2% in 2005, and 34.1% in 2010.Additional analyses within journals did not reveal any significantincreases of female first or senior authors within the 15-year timeperiod (p=NS). In 1995, had the highest percentage of female firstauthors (54.5%) while had the highest (52.4%) in 2000.had highestpercentage of female first authors in 2005 (57.9%) and 2010 (64.2%). CONCLUSION: Although the percentage of female pharmacists hasincreased over the past several years, this has not translated topharmacy-specific research literature.

416. Student College of Clinical Pharmacy provides communityservice for the Akron Area Agency on Aging. Christina McKenzie,Pharm.D. Candidate1, Natalie Kolehmainen, Pharm.D. Candidate1,David Shifrin, Pharm.D.,Candidate1, Susan M. Fosnight, R.Ph., CGP,BCPS2, Patrick J. Gallegos, Pharm.D., BCPS1; (1)Northeast OhioMedical University (formerly known as NEOUCOM), Rootstown,


OH; (2)Summa Health System, Akron, OH PURPOSE: Care managers have the opportunity to interview patientsin their home about medications. This environment providesdistinctive opportunities to discover what medications a patientactually takes versus what is prescribed. This information is valuablewhen making care decisions. Our purpose is to explain a uniquecommunity service program provided by the Northeast Ohio MedicalUniversity (NEOMED) Student College of Clinical Pharmacy (SCCP)organization to Akron Area Agency on Aging care managers toimprove their medication history taking skills and to evaluate the caremanager’s response to these sessions. METHODS: The NEOMED SCCP organization providedpresentations to the Akron Area Agency on Aging regarding the pearlsof medication history taking. A voluntary survey is currently inprogress to assess various items including, but not limited to:pertinence, level of comfort, application of covered skills, and overallperception of educational sessions. RESULTS: Verbal responses to the program have been positive. Thesurvey results are pending. Completed results will be presented at theAmerican College of Clinical Pharmacy Annual Meeting. CONCLUSION: This community service project provided a uniqueopportunity for students to help educate local care managersincreasing their skills in medication history taking.

Emergency Medicine

417. Insulin based glucose control audit for emergencydepartment observation unit patients. Joo Hyun Ha, B.S., M.S.1,Miles Hawley, M.D.2, Mary Beth Shirk, B.S., Pharm.D.1; (1)The OhioState University Medical Center, Columbus, OH; (2)The Ohio StateUniversity, Columbus, OH PURPOSE: To compare the efficacy and safety of continuousintravenous insulin (CIVI) and subcutaneous insulin (SCI) prescribingpractices in our Emergency Department’s Observation Unit (OU). METHODS: OU patients receiving insulin between March 1 and July23, 2010 were identified using a pharmacy database query. Only firstvisits were included for patients with multiple visits. All patientsreceiving CIVI during the study period were included (n=9). Patientsreceiving SCI were selected by convenience sampling (n=22). Thesafety (blood glucose (BG) <65 mg/dL and BG decrease ≥100mg/dL/hr) and efficacy of insulin therapies were evaluated.Comparisons were made using the unpaired t and Fisher’s exact tests. RESULTS: Thirty-one patients (43.5±14.7yrs) were included. Twentyone were managed as part of the OU hyperglycemia protocol.HgbA1C (3mos) was 10.96±2.75 (n=25), with no significantdifference between CIVI and SCI patients. CIVI rates were adjustedusing the hospital standard titration scale. Duration of CIVI was5:31±2:55 hrs. Seven violations of the titration protocol occurred in 5patients. Initial glucose was 535±173 and 393±135 mg/dL for theCIVI and SCI arms, respectively (p=0.021). The mean decrease in BGwas 313 mg/dL for CIVI (n=9), and 124 mg/dL for SCI (n=22,P=0.005). Hypoglycemic events occurred in 33% (3/9) and 4.5%(1/22) of CIVI and SCI patients, respectively (p=0.06). Nohypoglycemic events were associated with documented symptoms. Ofthe six CIVI patients with a BG <250 mg/dL, four did not receive aD5W infusion, per protocol requirements. BG decreased ≥100mg/dL/hr in 66% (6/9) CIVI patients. OU LOS was 23:17±8:00 hrs(CIVI), and 16:17±8.26 hrs (SCI) (P=0.04). One SCI patient wasadmitted for tight control during pregnancy. CONCLUSION: Nonsignificant safety and significant LOSdifferences favoring SCI were identified in this retrospectivenonrandomized trial, despite a significantly greater decrease in BGwith CIVI. These findings warrant further consideration as to whetherCIVI therapy can be used safely and effectively in the OU setting.

Endocrinology

418. Glucose control in cardiac surgery patients following IVinsulin discontinuation. Elyse R. Weitzman, B.S., Amy C. Donihi,Pharm.D.; University of Pittsburgh School of Pharmacy, Pittsburgh,PA PURPOSE: Studies have demonstrated that good glycemic control

using IV insulin for 3 days after cardiac surgery is associated withreduced morbidity and mortality. Our goal was to examine howeffectively patients are transitioned off of IV insulin at our institution. METHODS: We conducted a retrospective review of patients thatunderwent open-heart surgery at the University of Pittsburgh MedicalCenter between January and May 2011. Patients that died or weredischarged within 72 hours post-surgery were excluded.Demographics, lab values including glucoses, and LOS were collectedfrom electronic medical records. Incidence of hypoglycemia,hyperglycemia, and goal-range glucose values for the first 72 hoursfollowing IV insulin discontinuation were compared between patientswith and without a known diagnosis of diabetes. RESULTS: To date, 85 patients have been reviewed, 21 with diabetesand 64 without. There were no differences in age (63 vs. 60 years),BMI (30 vs. 27 kg/m2), SCr (1.4 vs. 1.3 mg/dL), and Hct (28 vs. 28%)between patients with and without diabetes. Patients with diabetes hadhigher A1C (6.9 vs. 5.7%, p<0.001) and higher pre-surgery BG (130vs. 111 mg/dL, p=0.002). There was no difference in LOS (24 vs. 17days). During the first 72 hours following IV insulin discontinuation,patients with diabetes had more glucose values>300mg/dL (3.6 vs.0.2%, p<0.001) and between 181-300mg/dL (34 vs. 10%, p<0.001).Patients without diabetes had more glucose values between 70-180mg/dL (62 vs. 90%, p<0.001). Neither group had a BG<40mg/dL;one patient with diabetes had a single hypoglycemic episode (BG= 56mg/dL). CONCLUSION: Glucose values in cardiac surgery patients followingIV insulin discontinuation are generally well-controlled, withpractically no incidence of hypoglycemia at our institution. Patientswith known diabetes had higher incidence of hyperglycemia, andfuture efforts will focus on achieving better glycemic control in thispopulation.

419. The effects of adding liraglutide to an urban type 2 diabeticpopulation. Milan Sharma, Pharm.D. Candidate1, Patrick Healy, RD,CDE, M.P.H.2, Mark Drews, M.D.2, Michelle Jacobs, Pharm.D.,CDE1; (1)Northeastern University Bouve College of Health Sciences,School of Pharmacy, Boston, MA; (2)Whittier Street Health Center,Roxbury, MA The effects of adding liraglutide to an urban type 2 diabetic population PURPOSE: Glucagon-like peptide-1 receptor agonists arepredominantly used as an adjunctive treatment for patients withuncontrolled type-2 diabetes and have been shown to accommodateweight loss in this population. This prospective observational studydocumented changes with the addition of liraglutide within a cohort ofpredominately African American patients enrolled in a diabeteseducation group in an ambulatory clinic in Roxbury, MA. METHODS: Thirteen patients were enrolled in an educationaldiabetes group where liraglutide was added to their diabetes regimenbetween January and April 2011. Data collected and evaluatedincluded A1c, weight, changes in the diabetes medication regimen,and occurrence of adverse effects. Liraglutide therapy was initiated at0.6 mg/day and titrated up to 1.8 mg/day with a single daily SQinjection. Data was collected at 2-week intervals during the patientsÕdiabetes education group meetings. RESULTS: Baseline characteristics included an average A1c of 8.5%,average weight of 241 pounds, 67% female, 85% African American,and the average number of medications prescribed for glycemia of1.67. The patients attended an average of 7.6 visits (range 2-14) duringthe study period. At the end of the study period, the average A1c was7.5%, average weight of 236 pounds (a 5 pound loss), and the endnumber of medications prescribed for glycemia of 1.58. Liraglutidewas generally well tolerated with adverse effects noted in 2 of the 13participants (diarrhea and nausea). Complete weight changeinformation over the study period and descriptive changes to thediabetes medication regimen will be presented. CONCLUSIONS: Adding liraglutide to a type 2 diabetic regimen inan urban population resulted in A1c improvement, small averageweight loss, and reduction of medication for glycemic control with atolerable side effect profile.

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Family Medicine

420. Evaluation of statin therapy in patients over 40 years old withdiabetes mellitus in a family medicine residency setting. SamanthaM. Allen, Pharm.D. Candidate, 20121, Roberta Farrah, Pharm.D.,BCPS2, Sandra C. Sauereisen, M.D.3; (1)University of PittsburghSchool of Pharmacy, Pittsburgh, PA; (2)UPMC St. Margaret Hospital,PA; (3)UPMC St. Margaret’s, Pittsburgh, PA PURPOSE: To compare current prescribing practices with an ADApractice guideline recommending all diabetic patients over 40 years ofage be prescribed statin therapy regardless of lipid levels if anadditional cardiovascular risk factor is present and to assesseducational opportunities for the family medicine residency program. METHODS: Retrospective chart review was conducted on 68diabetic patients >40 years old and not prescribed a statin betweenApril and June of 2011. Patient follow-up, medical history,prescription medication history, last lipid panel, additionalcardiovascular risk factors (smoking, hypertension, low LDL, earlyfamily history CVD), statin contraindications, and other documentedreasons for not receiving a statin were noted. Patients were consideredlost to follow-up if they had not been seen at the family health centerin > 6 months or did not obtain a requested lipid panel. RESULTS: Of 68 patients reviewed, 30 patients were lost to follow-up (44%), 14 patients had an LDL less than or within 10 points of goal<100 mg/dL (21%), 9 patients did not meet the ADA criteria for statintherapy (13%), 5 patients refused therapy (7%), 3 patients had acontraindication (4%), 3 patients were prescribed a diet/exerciseregimen (4%), and 5 patients did not have a reason documented (7%). CONCLUSION: The current diabetes practice guidelines recommendthat diabetic patients ≥40 years old with additional cardiovascular riskfactors receive a statin regardless of baseline lipid levels. Amongpatients retained for follow-up, physicians are predominantly reluctantto add an additional medication to a patient’s regimen if the patient isclose to or at LDL goal, suggesting an opportunity for physicianeducation on current ADA practice guidelines.

421. Evaluation of CHF Patients Not Prescribed an ACE/ARB in aFamily Medicine Residency Setting. Anne M. Butera, B.S.,Pharm.D. Candidate1, Roberta M. Farrah, Pharm.D.2; (1)University ofPittsburgh School of Pharmacy, Pittsburgh, PA; (2)UPMC St.Margaret Lawrenceville Family Medical Center, Pittsburgh, PA PURPOSE: Determine causes why qualifying patients withcongestive heart failure (CHF) had no prescribed angiotensinconverting enzyme (ACE) or angiotensin receptor blocker (ARB)regimen. Identify strategies to improve this quality measure METHODS: The January to March 2011 Quality Improvement (QI)report identified 56 patients with a CHF diagnosis and no prescribedACE/ARB regimen. Retrospective chart review confirmed CHFdiagnosis and analyzed current and prior medical history, medicationrecords, allergies and laboratory test results. Patient records weresorted based on the reason stated for not prescribing an ACE/ARBregimen. RESULTS: Most patients the report listed did not meet the QIinitiative criteria. Of 56 CHF patients meeting the criteria, 44 receivedACE/ARB medication and one did not have CHF. Eleven of the 56patients had an accurate CHF diagnosis but no prescribed ACE/ARBmedication. Records for three of the 11 patients contained cleardocumentation explaining why an ACE/ARB regimen was notadvised, e.g., hyperkalemia or renal stenosis. For three patients,records suggested concern about renal function; however, informationreviewed suggested a possible retrial since serum creatinine returnedto baseline. ACE was discontinued for two patients due to cough;however, an ARB was not tried. ACE was discontinued for twopatients with no clear reason stated. For one patient there was nodocumentation regarding any ACE/ARB medication. CONCLUSION: Record review for CHF patients not prescribed anACE/ARB regimen produced the following conclusions: For CHFpatients, the study indicates need for educational intervention thatsupports the medical practice standards for care. Quality improvementinitiated education should mandate: Continual monitoring forelevated potassium or serum creatinine to assess possible reinitiatingof an ACE/ARB regimen Patient records must state clearly why anACE/ARB regimen is not prescribed for a CHF patient

Geriatrics

422. Impact of a pharmacist as a member of an interprofessionalteam to identify and reduce medication related problems duringtransitions of care from skilled nursing facilities (SNFs) to home.Karen Soong, Pharm.D. Candidate1, Daniel A. Zlokas, Pharm.D.Candidate1, Shachi Tyagi, M.D.2, Denise Z. Hodes, M.S.W.2, AmeliaGennari, M.D.2, Christine M. Ruby, Pharm.D., BCPS, FASCP1;(1)University of Pittsburgh School of Pharmacy, Pittsburgh, PA;(2)UPMC Shadyside Hospital, Pittsburgh, PA PURPOSE: Transitions of care may involve multiple medicationchanges that lead to uncertainty about medication regimens andpotential errors. This project addressed medication related problemsidentified during telephone calls to patients discharged from threeSNFs. METHODS: An interprofessional team, centered in an outpatientgeriatric clinic, composed of a pharmacist, social worker, andphysician collaborated with three SNFs to develop a protocol toimprove continuity of care for returning clinic patients. Informationfrom the recent hospitalization and SNF stay included: dischargemedication lists/summaries and medication administration records.Within 3 business days of discharge, a pharmacist and pharmacystudent contacted patients or family representatives via telephone toidentify drug therapy problems, perform medication reconciliation,and update the electronic medical record (EMR). Referrals were madeto the social worker if necessary. Therapeutic recommendations weredocumented in the EMR and communicated to the interprofessionalteam. RESULTS: The pharmacy team contacted 10 patients, of which 8 had> 10 medications. All 10 patients (100%) were found to havemedication related problems, with the most frequent problems beingunnecessary drug therapy (50%) and adherence issues (50%). Thepharmacist identified 26 medication-related problems (mean 2.6 perpatient), made 17 recommendations and provided 22 counselingpoints. Common co-morbidities included: hypertension (70%),osteoporosis (50%), and pain (30%). Only 1 patient requiredhospitalization within 30 days after the encounter which was due to aninfectious process unrelated to the previous admission. CONCLUSIONS: Pharmacists have a crucial role as part of aninterprofessional team to identify and reduce the number ofmedication related problems in geriatric patients during transitions ofcare.

423. Classifications of Drug Related Problems Discovered DuringSenior Brown Bag Medication Reviews. Ashley M. Tocco,Pharm.D., IV, Student1, Feng Chang, Pharm.D.2, Megan E. Kleinow,Pharm.D.3, Jamie M. Hwang, Pharm.D.4, Candice L. Garwood,Pharm.D.1, Hanan S. Khreizat, Pharm.D.3, Mary Beth O’Connell,Pharm.D.1; (1)Wayne State University, Eugene Applebaum College ofPharmacy and Health Sciences, Detroit, MI; (2)University ofWaterloo, School of Pharmacy, Waterloo, ON, Canada; (3)Henry FordHealth System, Detroit, MI; (4)Henry Ford Piersen Clinic, GrossePointe Farms, MI PURPOSE: To quantify and classify drug related problems (DRPs)discovered during brown bag medication reviews and determinerecommendation acceptance. METHODS: Medication reviews were conducted in senior centersand high-rises (N=9). A medication calendar and DRPrecommendations were given to each senior. After 3 months, a surveywas sent to seniors to capture implementation of recommendations (38returns, 81% DRPs). After two training sessions, two pharmacists (10coding pairs) classified each DRP using a modified PCNEClassification Scheme for Drug-Related Problems (V6.2; ), Severityof Error in Medication Order (AJHP 99;56:2449), and Value ofService (AJHP 99;56:2449-50) scales. Disagreements were resolvedby two additional investigators. Descriptive statistics were utilized forquantification and Kappa coefficients calculated to determineinterrater reliability (classification agreements) per PCNE domains,severity and value scales, and by pairs (data not included); SPSS v19. RESULTS: The seniors were 76.6 ± 8.5 years old. They had 3.7 ± 2.4DRPs per patient (range 0 – 10). Problems were related to adversereactions (30%), treatment effectiveness (28%), other (21%),treatment costs (13%), and information (8%). DRP causes were due to


drug selection (40%), dose (23%), patient issues (16%), drug useprocess (12%), other (7.4%), drug formulation (0.5%), and treatmentduration (0.5%). Interventions required drug changes (44%),prescriber input (37%), patient counseling (18%), or other (1%).Seniors implemented 54% of the recommendations. Most DRPseverities were classified as significant (59%) or minor (35%). Mostrecommendation values were classified as significant (50%) orsomewhat significant (46%). Kappa coefficients were PCNE problem(0.573), PCNE cause (0.39), PCNE intervention (0.728), severity(0.231), and value (0.176). CONCLUSION: Senior medication reviews identified importantDRPs with about half of the recommendations implemented. Interraterreliability with the scales was quite variable, which might be correctedwith more training and enhanced explanation of individual scalesubdomains, especially for severity and value.

424. Evaluation of patient education on preventive healthmeasures and poison control center awareness during seniorbrown bag medication reviews. Nishi S. Gupta, Hons.B.S.1, FengChang, Pharm.D.1, Megan E. Kleinow, Pharm.D.2, Jamie M. Hwang,Pharm.D.3, Candice L. Garwood, Pharm.D.4, Hanan S. Khreizat,Pharm.D.2, Mary Beth O’Connell, Pharm.D.4; (1)University ofWaterloo, School of Pharmacy, Waterloo, ON, Canada; (2)Henry FordHealth System, Detroit, MI; (3)Henry Ford Piersen Clinic, GrossePointe Farms, MI; (4)Wayne State University, Eugene ApplebaumCollege of Pharmacy and Health Sciences, Detroit, MI PURPOSE: To evaluate patient education on preventive healthmeasures and poison control center awareness achieved throughbrown bag medication reviews for seniors. METHODS: Brown bag medication reviews were conducted insenior centers and high rises (N = 9). A medication calendar and list ofrecommendations were provided. Seniors were also educated onpreventive health measures including vaccinations, calcium, vitaminD, and multivitamin supplementation. Seniors were informed aboututilizing poison control center for unintended medication ingestionand provided with magnets or stickers with the center’s contactnumber. A follow-up survey was sent 3 months after. Unreturnedsurveys were followed up by telephone. RESULTS: 64 follow-up surveys were completed. Of the seniors whowere previously not following preventive measures: 39.3% werewilling to get the flu vaccine based on the pharmacists’recommendations; 75.6% considered getting or already got thepneumonia vaccine; 71.2% increased or wanted to increase their dailycalcium intake; 67.3% were taking or considering taking vitamin Ddaily; and 68.8% started taking a multivitamin or were consideringtaking them. An appreciable 75.4% of the seniors had alreadydiscussed or were considering discussing the pharmacists’recommendations with their physicians. Prior to the brown bagmedication review, 17% of the seniors did not know how to act in caseof accidental medication ingestion compared to 0% in the follow-upsurvey. Only 14.2% of the seniors would have called a poison controlcenter compared to 37.9% in the follow-up survey. Seniors also ratedthe session as being highly educational and found the poison controlcenter stickers or magnets to be very helpful. CONCLUSION: Brown bag medication reviews can be an effectivesetting to help seniors implement preventive health measures. Byincorporating poison control center education into the review, seniorsbecame more aware and more prepared to handle accidentalmedication ingestion.

425. Patient satisfaction and self-perceived knowledge gainedduring senior brown bag medication reviews. Nishi S. Gupta,Hons.B.S.1, Feng Chang, Pharm.D.1, Megan E. Kleinow, Pharm.D.2,Jamie M. Hwang, Pharm.D.3, Candice L. Garwood, Pharm.D.4, HananS. Khreizat, Pharm.D.2, Mary Beth O’Connell, Pharm.D.4;(1)University of Waterloo, School of Pharmacy, Waterloo, ON,Canada; (2)Henry Ford Health System, Detroit, MI; (3)Henry FordPiersen Clinic, Grosse Pointe Farms, MI; (4)Wayne State University,Eugene Applebaum College of Pharmacy and Health Sciences,Detroit, MI PURPOSE: To examine patient satisfaction and self-perceivedknowledge gained during brown bag medication reviews for seniors. METHODS: Brown bag medication reviews were conducted in

senior centers and high rises (N = 9) for seniors over the age of 60 andon 5 or more medications. Each appointment was scheduled for 45 –60 minutes. A medication calendar and a list of recommendations weregiven. Seniors were asked to complete a 13-items satisfactionquestionnaire following the session and rate the program’s helpfulnessagain in a follow-up survey at 3 months. Each item on the satisfactionquestionnaire was ranked 1–5 (strongly disagree–strongly agree). Self-perceived learning was reported using an 8-items survey. Each itemwas ranked 1–5 (very little–lots). Unreturned surveys were followed-up over the phone. RESULTS: 64 seniors completed the satisfaction questionnaire.Overall, the seniors were highly satisfied with the program. All itemson the survey were ranked between 4.44–4.90. The highest rankeditems were: having enough time to ask questions (4.90); time andplace of the review were convenient (4.83); trust in the pharmacist’sanswers (4.83); and better understanding of their medications (4.83).The lowest ranked item was perceived resolution of their healthproblem (4.44). At 3 months follow-up, 98% still ranked the brownbag medication review as helpful. Self-perceived knowledge gainedwas rated between 4.40–4.71. The highest ranked items were learninghow to use their medications (4.71); when to correctly take themedications (4.66); and learning the purpose of their medications(4.64). Perceived knowledge gained in understanding medication sideeffects was rated the lowest (4.40). CONCLUSION: Seniors were highly satisfied with the brown bagmedication reviews. They felt a high degree of learning and found theprogram helpful. Individual items ranked demonstrated uniqueadvantages and limitations of such programs.


426. Evaluation of smoking rates and nicotine dependence withinSullivan University System. Carrie M. Armstrong, M.B.A., Pharm.D.Candidate1, James D. Nash, Pharm.D., M.P.H., BCPS, CGP1, CarolynW. Chou, Pharm.D.2, Megan E. Rose, Pharm.D.1; (1)SullivanUniversity College of Pharmacy, Louisville, KY; (2)Pfizer, Inc.,Louisville, KY PURPOSE: To assess and evaluate the prevalence and economicimpact of smoking, the degree of nicotine dependence and determinethe readiness to quit smoking among faculty and students within theSullivan University System (SUS). SUS has campus locations inLexington and Louisville, Kentucky. METHODS: The population of SUS consists of all faculty, staff andstudents within all educational programs, ranging in age from 18 yearsor older (n = 5,980). All were asked to voluntarily participate in ananonymous online survey through Survey Monkey. The survey,developed by Pfizer, used the Fagerstrom test for nicotine dependenceand a readiness to quit tool, created by Pro-Change Behavior Systems,Inc., to determine the prevalence of nicotine dependence. Theparticipant’s responses were measured on a 10 point scale where thelarger values represent higher nicotine dependence. The readiness toquit assessment determined whether the participant was genuinelyready to quit smoking. RESULTS: Currently undergoing analysis. CONCLUSION: In Kentucky, the smoking rate is 27.6%.Conservatively, healthcare costs from smoking are estimated at $3,400per person annually. Upon applying this to SUS, there are potentially1,650 employees and students who currently smoke. If sixteensmokers (1%) quit, there is a projected annual cost savings of $56,100.This study will contribute to the development of a smoking cessationprogram made available to faculty and students through theInterNational Center for Advanced Pharmacy Services (INCAPS)within the SUS. This will allow patients to meet with a clinician for anindividualized treatment plan that meets their needs.


427. Identification of reasons for discontinuation of dabigatran inan outpatient cardiology office. Ruth Seiffert, Pharm.D. Candidate1,Bethany E. Helms, Pharm.D.1, Linda Snyder, M.S.N., CRNP1, DavidS. Schwartzman, M.D.2, Deanne L. Hall, Pharm.D.3; (1)University ofPittsburgh Medical Center, Pittsburgh, PA; (2)University of Pittsburgh,Pittsburgh, PA; (3)University of Pittsburgh School of

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Pharmacy/University of Pittsburgh Medical Center, Pittsburgh, PA PURPOSE: To identify reasons for discontinuation of dabigatran inpatients newly prescribed dabigatran or transitioned from warfarin anddetermine if discontinuation was due to an adverse event. METHODS: Retrospective review of electronic medical records toidentify patients with non-valvular atrial fibrillation who wereprescribed dabigatran between November 1, 2010 and June 30, 2011within the University of Pittsburgh Medical Center CardiovascularInstitute’s University Center office. Progress notes, telephonecommunications and medication lists were reviewed to collect the startand stop date of dabigatran, and when stopped the reason fordiscontinuation of dabigatran. Where a specific reason was not noted,the patient’s physician or nurse practitioner provided clarification. RESULTS: Preliminary data revealed 90 patients were prescribeddabigatran during the identified time frame. Twenty-nine (32%) ofpatients discontinued dabigatran. Of these 29 patients, 8 discontinueddabigatran due to gastrointestinal side effects (27%). An adverse eventwas the reason for discontinuation in 14% of these patients (3gastrointestinal bleed, 1 possible transient ischemic attack). Otherreasons for discontinuation include cost (10%) and drug interactions(10%). One patient stopped dabigatran due to chest pain, and 2patients no longer required anticoagulation. The reason fordiscontinuation in 8 patients has yet to be determined. CONCLUSION: One-third of patients prescribed dabigatrandiscontinued use, with the most common reason for gastrointestinalside effects. Both bleeding and thrombotic adverse events were found.Data collection and analysis is ongoing. The findings of thisevaluation may provide background for the office to conduct furtheranalysis of the data to identify risk factors for patients that may be ofhigh risk for adverse events with dabigatran.

Herbal/Complementary Medicine

428. Ethnopharmacology comparison Nicaragua and Peru. AnnaBondar; University of Pittsburgh, Pittsburgh, PA PURPOSE: It is known that Latin Americans in the U.S. often utilizehome remedies for many common ailments; however, there is a lackof research in the relationship between health care access and theprevalence of natural remedies. The purpose of this comparative studyin Trujillo, Perú and León, Nicaragua was to determine therelationship between the health care system and patients’ decisions toseek alternative forms of medicine in two societies, distinct in bothgeography and economic level. METHODS: This exploratory research project was conducted inNicaragua in the summer of 2010 and in Perú in May 2011. Theauthor conducted structured interviews of both health careprofessionals and patients in various settings: hospitals, outpatientclinics, pharmacies, and natural medicine vendors. Qualitativeresearch methods were utilized, and the qualitative portion will beanalyzed prior to the ACCP Annual Meeting. The University ofPittsburgh’s IRB approved this project. RESULTS: A total of 29 interviews were conducted (15 in Nicaraguaand 14 in Peru). Trujillo, Perú offers more public and private healthservices for its residents than León, Nicaragua. Sixty percent of theNicaraguan sample size and eighty-five percent of the Peruviansample size cited use of natural medicine. A language barrier existsmore often in Perú than in Nicaragua, because of indigenouslanguages, so health professionals cite this is a reason for a significantportion of the use of natural remedies in Perú. CONCLUSION: Although there is better access to western medicalservices in Trujillo, Perú, there is simultaneously more widespread useof natural medicine. Therefore, decreased access to medical servicesdoes not directly correlate with the use of alternative medicine. U.S.health care professionals must consider several factors, includingaccess to healthcare, when discussing the use of western and naturalmedicine with Latino patients.

HIV/AIDS

429. An apparent drug interaction between warfarin and theantiretroviral TRIO regimen. Amulya Vanguri, Pharm.D.Candidate, Michelle D. Liedtke, Pharm.D., BCPS, R. Chris Rathbun,Pharm.D., BCPS; University of Oklahoma College of Pharmacy,

Oklahoma City, OK PURPOSE: Drug-drug interactions between warfarin andantiretrovirals have been reported in the literature, but limitedinformation exists on the interaction potential with newerantiretroviral agents. The antiretroviral TRIO regimen consists ofdarunavir, ritonavir, raltegravir, and etravirine and has beendemonstrated to be highly effective for HIV-infected patients withextensive drug resistance. We investigated whether weekly warfarindose requirements were changed following the initiation of the TRIOregimen in an HIV-infected man. METHODS: International normalized ratio (INR) results and weeklywarfarin dose for a 51-year old man with AIDS and recurrent deep-vein thrombosis (DVT) were reviewed from April 2008-May 2011.Electronic medical records and hard-copy charts were reviewed andconcomitant medications recorded. Weekly warfarin dose and INRresults were compared using an unpaired t-test with an alpha of 0.05 todefine significance. RESULTS: A total of 39 and 43 INR values were available before andafter TRIO regimen initiation, respectively. The patient’s target INRgoal range was 2.0–3.0. The mean weekly warfarin dose (n = 90weeks) on emtricitabine monotherapy was 13.3 mg (95% CI: 12.7,13.8). Following initiation of the TRIO regimen in January 2010, themean weekly warfarin dose (n = 71 weeks) increased to 19.3 mg (95%CI: 18.5, 20.1; p<0.001). The patient’s plasma HIV RNA level becameundetectable within 12 weeks and remained suppressed throughout theremaining evaluation period, suggesting adherence with antiretroviraltherapy. Target INR values were achieved upon titration to the higherweekly warfarin dose; mean INR values before and after TRIOregimen initiation were consistent (2.8 vs. 2.7, respectively; p=NS).Concomitant medications during the two periods were similar. CONCLUSION: Interactions between warfarin and antiretrovirals arelikely and vary depending on the specific agents. An increased weeklywarfarin dose requirement is predicted when warfarin is usedconcurrently with the antiretroviral TRIO regimen.

Infectious Diseases

430. Do differences between quantitative viral plaque assaysexplain variability among pre-clinical respiratory syncytial virusstudies in animals?Indrani Kar, Pharm.D. Candidate, 2013, Jacob G. Orend, B.S., KerryM. Empey, Pharm.D., Ph.D.; University of Pittsburgh School ofPharmacy, Pittsburgh, PA PURPOSE: Respiratory syncytial virus (RSV) infects nearly allchildren by the age of two. To study RSV pathogenesis, RSV isquantified for use in rodent models. Plaque assays are the goldstandard for RSV quantification, yet assay differences may contributeto variability in RSV inoculum quantification. We hypothesize RSVtiters will vary significantly between two commonly used plaqueassays, secondary to differences in permissiveness and viral growthamong the two cell types used for each assay. Quantifying thesedifferences will improve consistency among animal models andreduce variability in data among labs. METHODS: The Hematoxylin and Eosin (H&E) and Antibodyplaque assays were optimized, compared, and their linear range ofquantification established using Hep-2 and Vero cells, respectively.Plaque morphology and cytopathic effect were evaluated for each celltype. RESULTS: An acceptable variation in RSV titers from individualplaque forming units (pfu) per well is 0.5 log or a coefficient ofvariance less than 35% as calculated from linearity curves for both celllines. The limit of quantification for RSV line 19 was 7 plaques perwell in H&E and 15 plaques per well for antibody assay. The limit ofquantification for RSV A2 was 8 plaques per well for both assays. Thetwo plaque assays did not result in significantly different RSV titers. CONCLUSIONS: RSV quantification variability may not result fromplaque assay differences, as hypothesized. Our results suggest thatcounting too few plaques, which may be assay-dependent, and lack ofassay optimization may introduce error among assays. Therefore,variability among animal studies may result from quantifying titerswithout considering these factors. Using limits of quantification andoptimization (regardless of assay type) before inoculating mice toquantify precise RSV titers can minimize variability in animal models


and increase confidence in future testing of RSV therapeutics andvaccines.

431. Adverse drug events secondary to sulfamethoxazole/trimethoprim in HIV–infected hospitalized patients. Caitlin L.Shamroe, Pharm.D. Candidate1, P. Brandon Bookstaver, Pharm.D.,BCPS (AQ-ID), AAHIVE1, Celeste N. Rudisill, Pharm.D.1, Robert R.Moran, Ph.D.2; (1)South Carolina College of Pharmacy- USCCampus, Columbia, SC; (2)Health Sciences Research Core -University of South Carolina, Columbia, SC PURPOSE: In the hospital setting, sulfamethoxazole-trimethoprim(SMX/TMP) is commonly used in management of Pneumocystisjiroveci pneumonia (PCP) in HIV-infected patients. Hyperkalemia andincreased serum creatinine (SCr) are known adverse events (AE)associated with SMX/TMP therapy. The study goals are to determinethe incidence of hyperkalemia and elevated SCr in HIV-infectedpatients receiving SMX/TMP and assess a dose-dependentrelationship. METHODS: Institutional Review Board approval was granted priorto initiation of this retrospective analysis. HIV-infected hospitalizedpatients receiving a minimum of 3 consecutive days of SMX/TMPwere eligible for study inclusion. The primary endpoints of incidenceof hyperkalemia and elevated SCr were defined as potassium greaterthan 5.0 mEq/L (or 6.0 mEq/L for severe hyperkalemia), and anincrease of 0.5 mg/dL or a 50% increase above pre-treatment baseline,respectively. For secondary evaluation, the population was dividedinto two groups: “high-dose” SMX/TMP (> 10 mg/kg/day) and “low-dose” SMX/TMP (<10 mg/kg/day). c2 analysis was used for test ofdifference in nominal data. RESULTS: Ninety patients met study inclusion criteria with anaverage age of 42 years. Of these, 93.3% had an indication for PCPtreatment or prophylaxis. The incidence of elevated SCr, hyperkalemiaand severe hyperkalemia was 25.5 %, 35.5 % and 7.7%, respectivelywith an average time to event of 8.7 days, 8 days and 11.9 days. In thehigh-dose group (n = 40) the incidence of elevated SCr was 22.5%compared to 28% in the low-dose group (p=NS). The occurrence ofhyperkalemia was 50% (10% severe) in the high-dose group versus24% (8% severe) in the low-dose group (p<0.05). CONCLUSION: Results suggest a significant rate of elevated SCrand hyperkalemia in hospitalized HIV-infected patients receivingSMX/TMP. Prudent monitoring of renal function and potassium isimportant for HIV-infected patients receiving SMX/TMP, especially incombination with other host risk factors or agents with similar AEprofiles.

432. Management of Stenotrophomonas maltophilia in pediatricpatients: a retrospective evaluation. Ashley E. Jones, Pharm.D.,Candidate, Kalen B. Porter, Pharm.D., BCPS, AE-C; University ofGeorgia College of Pharmacy, Augusta, GA PURPOSE: Stenotrophomonas maltophilia is an opportunisticorganism that is commonly associated with respiratory tractcolonization but can become clinically significant in certain patientpopulations (cystic fibrosis, immunocompromised, catheterized, andmechanically ventilated). The organism is known to be highly resistantto many antimicrobials. The aim of this study was to evaluate clinicaloutcomes for antimicrobial treatment versus no treatment in pediatricpatients with positive cultures for Stenotrophomonas maltophilia.METHODS: Electronic medical records from an academic medicalcenter were retrospectively reviewed to identify pediatric patients witha documented isolate for Stenotrophomonas maltophilia from January2009 – June 2011. Clinical outcomes were evaluated to assess theimpact of antimicrobial treatment versus no treatment; a positiveoutcome was defined as improvement or maintenance of clinical statusand a negative outcome was defined as worsening of clinical status.Susceptibility data for trimethoprim-sulfamethoxazole, ceftazidime,ticarcillin-clavulanate, and chloramphenical were also obtained. RESULTS: Results are pending, but will be completed by August2011. CONCLUSION: Conclusion is pending.

433. Vancomycin in combination with Naficillin demonstratessynergy against heteroresistant vancomycin-intermediate

Staphylococcus aureus (hVISA). Amy Suen, B.S., Samira MGaronzik, Pharm.D., Brian T. Tsuji, Pharm.D.; Laboratory forAntimicrobial Pharmacodynamics University at Buffalo, StateUniversity of New York, Buffalo, NY PURPOSE: Combination agents with different mechanisms of actionare a therapeutic option to overcome decreased susceptibility toglycopeptides in hVISA infections. Vancomycin and β-lactams haveshown prelimary reports of synergy at sub-inhibitory concentrations.Our objective was to investigate the pharmacodynamics ofvancomycin combined with naficillin to determine if synergy ispresent at clinically relevant concentrations. METHODS: The killing effects of vancomycin and naficillin againsthVISA PFGE type USA300 at 106 CFU/mL were observed in 48 hrtime kill experiments. Time kill experiments were performed forvancomycin at varying concentrations (0, 0.5, 1, 2, 4, 8, 16, 32, 64,128 mg/L) to characterize vancomycin pharmacodynamics. Timepoints were taken at 0, 1, 2, 4, 8, 24, 28, 32, and 48 hr. Time kills atvarying concentrations of naficillin alone (0, 1, 16, 64 mg/L) and incombination with vancomycin were performed at the same timepoints. Changes in log10 CFU/mL at 48h vs. log ratio area were fit to aHill-type mathematical model. RESULTS: Vancomycin monotherapy against 106 CFU/mL atconcentrations of 8mg/L to 128 mg/L showed a log decrease of 3.8 to5.8 CFU/mL by 48 hours. At lower concentrations of vancomycinfrom 0 mg/L to 4 mg/L, a log increase of 2.9 CFU/mL was observed at48 hr. Therapy with 32 mg/L vancomycin combined with 1, 16, or64mg/L of naficillin and 128 mg/L vancomycin combined with 1, 16,or 64 mg/L showed bacterial killing effects to below detectable limitof 102 CFU/mL with a maximal log decrease of 4.8 CFU/mL at 24 h.The pharmacodynamics of vancomycin was Emax: 8.4, EC50: 7.6, andH: 28 (R2 ≥ 0.98 for all experiments). CONCLUSIONS: Combination therapy of vancomycin and naficillindemonstrated synergy against hVISA at high concentrations ofvancomycin and improved maximal killing. To combat increasingvancomycin resistance, utilization of vancomycin with b-lactams maybe used to treat recurrent hVISA infections in patients.

434. The Hsp40 co-chaperone Jjj1 is a negative regulator offluconazole resistance in Candida glabrata. Sarah G. Whaley, B.S.,Kelly E. Caudle, Pharm.D., Ph.D., Katherine S. Barker, Ph.D., P.David Rogers, Pharm.D., Ph.D.; University of Tennessee College ofPharmacy, Memphis, TN PURPOSE: In Saccharomyces cerevisiae, transcription factors Pdr1and Pdr3 regulate expression of ABC transporters that confer azoleresistance. Pdr3 is negatively regulated by the Hsp70 protein Ssa1.Hsp70s’ chaperone activities are regulated by Hsp40 proteins of theDnaJ family. We observed the DnaJ protein Jjj1 to be differentiallyexpressed in response to fluconazole in the related yeast Candidaglabrata. The purpose of this study was to determine if Jjj1 influencesfluconazole resistance and if Pdr1 and its downstream target ABCtransporters, Cdr1, Pdh1 and Snq2 are involved. METHODS: Strains of C. glabrata disrupted for JJJ1 wereconstructed in wild-type and pdr1Δ strains. Fluconazole susceptibilitytesting was performed using CLSI methods. Gene expression of JJJ1,PDR1, CDR1, PDH1, and SNQ2 was measured by relative qRT-PCR. RESULTS: At 48 hours the MIC of wild-type was 8μg/mL. Pdr1Δexhibited increased susceptibility with an MIC of 2μg/mL. When JJJ1was disrupted in the wild-type strain (jjj1Δ), the MIC increased to64μg/mL, but only increased to 4μg/mL when both PDR1 and JJJ1were disrupted (pdr1Δjjj1Δ). In jjj1Δ the expression of CDR1 wasincreased approximately 6-fold over the wild-type strain. The level ofCDR1 expression in pdr1Δjjj1Δ was not significantly different frompdr1Δ. There were no significant differences in PDH1 and SNQ2expression in any of the strains tested. CONCLUSIONS: We show here that Jjj1 is a negative regulator offluconazole resistance, as disruption of this gene leads to decreasedfluconazole susceptibility. This process appears to be mediated by theABC transporter Cdr1, but not Pdh1 or Snq2, and likely involvesPdr1. The role of Hsp70s in this process is currently underinvestigation. Our findings allow for a better understanding of theregulation of fluconazole resistance in C. glabrata and potentiallyother pathogenic fungi, and may lead to novel therapeutic strategies toprevent and overcome azole resistance.

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Medication Safety

435. Identifying optimal dosages of drugs requiring weight-basedcalculations in over and underweight populations. Nicholas P.Wytiaz, Pharm.D., (c)1, Sandra L. Kane-Gill, Pharm.D., M.S., FCCM,FCCP1, Mitchell S. Buckley, Pharm.D.2, Lisa M Thompson,Pharm.D.2, Kristina Muzykovsky, Pharm.D.3, Henry Cohen, M.S.,Pharm.D., FCCM, BCPP, CGP3, Amy L. Seybert, Pharm.D.1;(1)University of Pittsburgh School of Pharmacy, Pittsburgh, PA; (2)St.Joseph’s Hospital and Medical Center, Phoenix, AZ; (3)KingsbrookJewish Medical Center, Brooklyn, NY PURPOSE: To identify dosage ranges of high-risk medicationsrequiring weight-based dosing in over and underweight populations tobetter understand real-world dosing and help provide a foundation forstandardized guidelines. METHODS: A prospective, multi-center, observational study inwhich new and/or discontinued orders for target high-risk medicationswere evaluated in adult patients admitted to a cardiac intensive careunit at three institutions during 6-week periods. Intravenous high-riskmedications were selected from the Institute for Safe MedicationPractice’s List. Patient data collected included sex, age, race, height,weight, serum creatinine, dialysis use, and medications received. Drugdata included drug name, dose, concentration, route, frequency, andrate. RESULTS: A total of 857 medication orders for 11 different high-riskmedications were reviewed. 263 doses were evaluated for six differentvasoactive medications. Across all weight categories, dose rangesgreatly varied for each drug and were as follows: dobutamine 2.29-10.05 mcg/kg/min, dopamine 1.00–200.00 µg/kg/min, milrinone0.19–1.04 µg/kg/min, nitroglycerin 0.06–0.85 µg/kg/min,norepinephrine 0.007–10.00 µg/kg/min, and phenylephrine 0.10–2.00µg/kg/min. Highest average doses were observed in dopamine andnorepinephrine for normal, phenylephrine for overweight, dobutaminefor obese, and milrinone and nitroglycerin for morbidly obese. Fornon-vasoactive drugs, 371 doses were evaluated for five differentmedications in 97 unique patients. Across all weight categories, doseranges again greatly varied for each drug and were as follows:fentanyl 0.0018–0.40 µg/kg/min, heparin 3.93–26.00 units/kg/hr,midazolam 0.02–20.00 µg/kg/min, propofol 5.00–101.70 µg/kg/min,and rocuronium 3.00–12.00 µg/kg/min. Highest average doses wereobserved in heparin for normal, propofol and fentanyl for overweight,and midazolam for obese. CONCLUSION: A wide variance was seen in the doses used acrossweight classifications. Increases in dosing did not necessarily correlatewith increases in weight. The vasoactive drugs were within the dosingrange provided in the package inserts regardless of weightclassification while heparin and the sedatives were typically dosedoutside the recommendations.

436. Simvastatin safety pharmacist intervention study. KatherineM. Crabb, Pharm.D. Candidate1, Marion Wofford, M.D., M.P.H.2,Daniel M. Riche, Pharm.D., BCPS, CDE3; (1)The University ofMississippi School of Pharmacy, Jackson, MS; (2)University ofMississippi Medical Center, Jackson, MS; (3)The University ofMississippi Schools of Pharmacy and Medicine, Jackson, MS PURPOSE: Recently, the FDA issued a drug safety notice pertainingto simvastatin. Simvastatin 80 mg per day is associated with anincreased risk of myopathy and rhabdomyolysis and should not bestarted in new patients. Additionally, recommendations were made toreduce simvastatin doses in the presence of concomitant interactingmedications. The purpose of this study is to identify patients seen inInternal Medicine university-based clinics who are at increased risk ofmyopathy and rhabdomyolysis according to the FDA safety alert andto intervene by alerting their primary provider and offering pharmacistintervention. METHODS: This is a single-center, prospective cohort study ofpatients prescribed simvastatin in a contraindicated manner at aUniversity Medical Center. Investigational Review Board approval ispending. A quality assurance database was used to generate a list ofpatients who have been prescribed simvastatin 80 mg per day, whowere taking simvastatin with a contraindicated interacting medication,or who were taking simvastatin at a dose contraindicated with aninteracting drug. An email will be sent to each patient’s primary

provider explaining the nature of the adverse medication regimen.Four response options are available for the provider: (1) No change intherapy; (2) Primary provider to adjust regimen, (3) Pharmacist toadjust regimen, and (4) Refer to a lipid clinic. The primary outcome isto evaluate the total number and results of pharmacist interventions forthis patient population. RESULTS: The quality assurance database identified 246 patients of27 primary care providers qualifying for inclusion. Average age was64 years with an equal balance between males and females. Of thepatients prescribed simvastatin, 52% were receiving 80 mg per day.The most common interacting medications were calcium channelblockers, verapamil (4.5%), diltiazem (6.5%), and amlodipine (60%).

437. Development of a student pharmacist driven medicationreconciliation discharge program. Peter M. Sullivan, Student, AmyJurek, Student; Duquesne University, Mylan School of Pharmacy,Pittsburgh, PA PURPOSE: Hospital discharge is a major risk factor for medicationerrors and discrepancies for patients; resulting in adverse effects andhospital readmission. Evidence based studies are largely based on theadmission processes and lack discharge planning and patienteducation. We aim to develop a student pharmacist driven dischargemedication reconciliation and education program to decreasediscrepancies and increase caregiver knowledge in medicationmanagement. METHODS: A PubMed search was performed and 15 articles wereincluded which discussed medication reconciliation. Medicationreconciliation upon admission appeared to be the focus of mostprograms, while discharge programs were less evident. Details fromthese programs were adapted and combined with current pharmacybased models to develop a student pharmacist driven medicationreconciliation discharge program. RESULTS: Most institutions rely on nurses to perform the tasks ofmedication reconciliation upon admission. All studies reviewedshowed a decrease in medication errors and discrepancies afterimplementation of a formal program. The development of thisprogram will involve student pharmacists preparing for andconducting the discharge counseling sessions, under the supervision ofa preceptor. Discharge medication counseling sessions will bescheduled as 30 minute appointments, and patients will receive amedication information booklet and medication calendar. Themedication booklets will include: general medication informationincluding adverse effects and interactions to educate the patient andincrease compliance. CONCLUSION: Student pharmacists are at the best position toconduct medication reconciliation upon discharge, under thesupervision of a preceptor. They are eager to counsel, have anexpertise on medications, and have no associated cost when completedas a clerkship activity. Discharge is a crucial time for patients toreceive counseling on their medications due to the complexity, andchanges to their existing therapies.

438. Post-FDA safety statement medication use evaluation ofrosiglitazone. Keri L. Mills, Pharm.D. Candidate1, Marion Wofford,M.D., M.P.H.2, Daniel M. Riche, Pharm.D., BCPS, CDE3;(1)University of Mississippi School of Pharmacy, Oxford, MS;(2)University of Mississippi Medical Center, Jackson, MS;(3)University of Mississippi School of Pharmacy, Jackson, MS PURPOSE: Due to significant increase in risk of heart attack andheart-related deaths in patients taking rosiglitazone, the FDA hasdeveloped a Risk Evaluation and Mitigation Strategy (REMS) thatmust be implemented by November 18, 2011. The purpose of thisevaluation was to determine if patients of the general medicine andhypertension outpatient clinics of the University of MississippiMedical Center were currently being prescribed rosiglitazone orrosiglitazone-containing medications (new or continued prescriptions)and if patients had been appropriately counseled on the risks of thesemedications. METHODS: A search was conducted to identify patients in thegeneral medication and hypertension clinic who were prescribedrosiglitazone or rosiglitazone-containing product from January 2000 toFebruary 2011. Prescription histories were reviewed and compared tothe clinic notes. It was noted if the patient was: (1) Currently using


rosiglitazone; (2) Date of last known use; (3) Documentation ofcounseling; (4) Medication discontinuation/adjustment; (5) Reason themedication was altered; and (6) If a change was initiated by patient orphysician. RESULTS: Out of 186 patients with a history of rosiglitazone use,only 9 patients were currently taking rosiglitazone-containingmedications, while 33 patients discontinued or changed rosiglitazonedue to patient request or prescriber counseling. Counseling was notdocumented for any of the current rosiglitazone patients. In clinicnotes, patients requested the change due to advertisements, articles, oradvice of family. Prescribers most often cited the meta-analysispublished in the 2007 NEJM. 141 patents discontinued or changedwithout regarding to FDA safety statements, rather citing uncontrolledglucose, adverse effects, cost, or lost-to-follow up. CONCLUSION: While current use of rosiglitazone was small, thelack of documentation about cardiovascular risk counseling isconcerning. This project will continue by sending letters to physicianssuggesting therapy alteration and reinforcing documentation at allvisits, including medication counseling.

Men’s Health

439. Lack of association between statin therapy and testosteronedeficiency. Corey L. McEwen, Pharm.D. Candidate1, Marion Wofford,M.D., M.P.H.2, Daniel M. Riche, Pharm.D., BCPS, CDE3; (1)TheUniversity of Mississippi School of Pharmacy, Jackson, MS;(2)University of Mississippi Medical Center, Jackson, MS;(3)University of Mississippi School of Pharmacy, Jackson, MS PURPOSE: Recent studies evaluating the association of statintherapy and testosterone deficiency have had mixed results. Studiesthat have shown an association were done in male patients whoalready had erectile dysfunction (ED). This study was designed toexamine whether statin therapy is associated testosterone deficiency inmale patients with or without ED or any other confounding diseasestates. METHODS: This study is a retrospective chart review includingpatients with a testosterone level drawn at a university-basedoutpatient clinic over a 12-month period between June 2010 to June2011. Patient medical records were reviewed to determine statin useand testosterone deficiency (defined as testosterone level <280 ng/mLor presence of testosterone replacement). Demographic data wasobtained for all patients including age, race, and weight. Co-morbiddisease states of hypertension, diabetes, and the presence of erectiledysfunction medications was also obtained. Statin therapy wasconsidered associated with low testosterone levels if the patientinitiated any statin at least one month prior to their first recorded lowtestosterone level. Continuous data were evaluated using a t-test, whiledichotomous data were evaluated via c2 test. RESULTS: There were 93 patients meeting with testosterone drawnat the clinic during this 12-month period. The average age and weightof patients was 57.5 years and 230.6 pounds, respectively. There wasno association between statin therapy and testosterone deficiency.Although there is a numerically lower testosterone level in patientsreceiving statin therapy, there was no statistically significantdifference between groups (p=0.12). CONCLUSION: There is no association between statin therapy andpresence of testosterone deficiency.

Nephrology

440. Differential effect of IV iron compounds on intracellularreactive oxygen species (ROS) generation in aortic coronaryendothelial cells. Heena V. Patel, Pharm.D. Candidate, Alex J.Prokopienko, Pharm.D. Candidate, Nancy Gertzberg, A.S., PaulNeumann, A.S., Arnie Johnson, Ph.D., Amy Barton Pai, B.S.,Pharm.D., BCPS; Albany College of Pharmacy and Health Sciences,Albany, NY PURPOSE: Cardiovascular disease is the leading cause of death forend-stage renal disease (ESRD) patients and is highest among patientswith tunneled central venous catheters (TCVCs). This is likely due tooxidative stress and inflammation potentially exacerbated by IV ironadministration. The available IV iron compounds have differentstability profiles and we have previously shown there are significant

differences in free iron appearance among the available compounds[Pai et al. Biometals 2011]. The purpose of this study was toinvestigate whether IV iron products induce ROS generation incoronary endothelium. METHODS: Rat aortic coronary endothelial cells (RACEC) werecultured in 96-well plate. RACEC cells were treated with 0.05 mg/mLof iron sucrose (IS), iron dextran (ID), or ferumoxytol (FMX) for 60min then washed and measured serially for 60 min. Cells were alsotreated with lipoteichoic acid (LTA, 30 µg/mL), a Gram-positive cellwall component found in TCVC biofilm for 120 min. ROS generationwas probed for by fluorescence detection using dihydroethidium(DHE) (10 and 20 µM) for 15 minutes at 37ºC. DHE fluorescencevalues are reported as mean ± SD fluorescence intensity (MFI). Allexperiments are n ≥ 20. RESULTS: Incubation of RACEC with IS induced the highest ROSgeneration compared to control (549 ± 71 vs. 491 ± 83 MFI, p=0.01).ROS generation by ID and FMX was not different than controls.Treatment with LTA also significantly increased intracellular ROSproduction on average 21% greater than controls (p <0.001). CONCLUSION: The small molecular weight iron-carbohydratecomplex IS significantly increased intracellular ROS generation,likely due to the labile nature of the complex. These data indicate thatcardiac endothelial injury is induced differentially by IV ironcompounds. The Gram-positive cell wall component LTA alsosignificantly increased ROS generation. Further investigation of IViron and LTA on endothelial toxicity is warranted.

441. Management of serum calcium and phosphorous levels forthe prevention of mineral bone disease in chronic kidney diseasepatients on dialysis by multidisciplinary team care. Da-Hae Jun,B.S.1, Na Young Han, M.S.1, Eun Hee Ji, Ph.D.1, Hyoyoung Park,M.S.1, Suhnggwon Kim, M.D., Ph.D.2, Jin Suk Han, M.D., Ph.D.2,Curie Ahn, M.D., Ph.D.2, Yon Su Kim, M.D., Ph.D.2, Kwon Wook Joo,M.D., Ph.D.2, Kook-Hwan Oh, M.D., Ph.D.2, Dong Ki Kim, M.D.2,HyunAh Kim, Pharm.D.1, Wan Gyoon Shin, Pharm.D., Ph.D.1, HyeSuk Lee, M.S.3, Jung Mi Oh, Pharm.D.1; (1)College of Pharmacy,Seoul National University, Seoul, South Korea; (2)Division ofNephrology, Department of Internal Medicine, Seoul NationalUniversity Hospital, Seoul, South Korea; (3)Department of Pharmacy,Seoul National University Hospital, Seoul, South Korea PURPOSE: Although clinical pharmacists are at a unique position forpatient education and chart reviews, multidisciplinary team care(MTC) involving clinical pharmacists is not widely practiced inKorea. This study evaluated the effect of MTC on the management ofserum calcium and phosphorous in dialysis patients with clinicalpharmacists as part of the multidisciplinary team. METHODS: Electronic medical records and drug-related interventionrecords for 163 nephrology in-patients on dialysis admitted to atertiary teaching hospital from January 2009 to December 2009 wereretrospectively reviewed according to the 2009 KDIGO CKD-MBDguideline. Patients were categorized into a MTC group whichinvolved nephrologists, clinical pharmacists, nurses and nutritionists,and a non-MTC group. Regulation of serum corrected calcium (cCa)and phosphorous (P) levels at admission/discharge and appropriate useof related medications were analyzed by appropriate statistics withPASW 18. RESULTS: Baseline characteristics (including age, gender, etiologyof CKD, type/duration of dialysis, days of admission) of the 163patients were not significantly different between the two groups(MTC, n=100; non-MTC, n=63). The MTC group had more patientswith better regulation of serum cCa and P levels during admission(MTC cCa 51.9%, P 20.9% vs. non-MTC cCa 26.1%, P 15.5%). Whileserum P levels remained stable in the MTC group, serum P levelsincreased significantly above the baseline in the non-MTC group(serum P level difference, p-value=0.799 vs. p-value=0.002,respectively). The appropriate use of non-calcium phosphate binderswas significantly higher in the MTC group (MTC 66.67% vs. non-MTC 17.86%, p-value<0.001). CONCLUSIONS: MTC involving clinical pharmacists was effectivein improving the management of serum cCa and P levels in dialysispatients. Patient education on the administration of phosphate-binders,daily monitoring and interactions within the MTC team seem to becontributing factors. Better regulation of serum cCa and P levels by

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MTC may lead to prevention of CKD-MBD.

442. Knowledge, perceptions and adherence of ESRD patientsreceiving erythropoietic therapy and anemia management: Astudent-pharmacist based survey in an outpatient peritonealdialysis clinic. Karen Nenno, Pharm.D., Candidate1, Shailly Shah,Pharm.D. Candidate1, Oriyomi Alimi, Pharm.D. Candidate1, IrisHayes, L.S.W.2, Carol Dacko, R.N.2, Filitsa Bender, M.D.3, ThomasNolin, Pharm.D., Ph.D.1; (1)University of Pittsburgh School ofPharmacy, Pittsburgh, PA; (2)DCI, Inc., Pittsburgh, PA; (3)Universityof Pittsburgh School of Medicine, Pittsburgh, PA PURPOSE: Adherence is a vital component of anemia managementin patients who self-administer erythropoietic (EPO) therapy. Thepurpose of this study was to assess the knowledge, perceptions andadherence of home hemo- (HD) and peritoneal dialysis (PD) patientspertaining to EPO therapy and anemia management. METHODS: Cross-sectional surveys were administered to 28 PD andhome HD patients from February-March 2011. Questions weredesigned to determine patients’ understanding of their EPOprescription, hemoglobin (Hgb) concentrations, number of misseddoses, adverse effects, symptoms of anemia, and negative perceptionssurrounding EPO therapy. Survey responses were compared with eachpatient’s medical, laboratory, and medication profile for the months ofJanuary-March 2011, and were evaluated using descriptive statisticsand Fisher’s exact test. RESULTS: Nineteen patients (68%) knew their current EPOprescription. Five patients reported difficulty remembering toadminister EPO, but only one patient reported missing doses. Hgbconcentrations were >12.0 mg/dL and <10 mg/dL in fourteen (50%)and two patients, respectively. Patients who correctly recalled theirmost recent Hgb concentration (15/28; 54%) were more likely to be atHgb goal than those that did not [10/15 (67%) vs 2/13 (15%);P=0.009]. Patients with changes to their EPO prescription (21/28;75%) were less likely to know their regimen compared to those withunchanged prescriptions [12/21 (57%) vs 6/7 (86%); P=NS]. Patientsreceiving PD/HD >1.5 years (19/28) were less likely to be at Hgbgoal, [7/19 (37%) vs 5/9 (56%); P=NS] and to know their EPOprescription [10/19 (53%) vs 8/9 (89%); P=NS] compared to thosereceiving it ≤1.5 years. The most commonly reported (9/28, 32%)negative perception was needle stick. CONCLUSION: Our results suggest there is a relationship between apatient’s knowledge surrounding Hgb results, duration of PD/HD, andattainment of Hgb goal. Continuing patient education may improveanemia management in these patients.

Neurology

443. Medications associated with delirium in hospitalized subjects.Caroline A. Lindsay, B.S.1, Keiko A. Fukuda, B.A.2, S. AndrewJosephson, M.D.3, Vanja Douglas, M.D.3; (1)University of CaliforniaSan Francisco, School of Pharmacy, San Francisco, CA; (2)Universityof California San Francisco, Department of Neurology, StrokeSciences Group, San Francisco, CA; (3)University of California SanFrancisco, Department of Neurology, San Francisco, CA PURPOSE: To determine which medications are associated with thedevelopment of delirium in hospitalized subjects. METHODS: Non-delirious subjects admitted to the medicine,cardiology, and neurology inpatient services at UCSF wereprospectively enrolled in this cohort study. Subjects underwent adetailed baseline cognitive assessment within 24 hours of admissionand were followed until discharge or up to 6 days to detect new onsetdelirium. Home medication lists were collected from admission notes,and medications taken each day during the hospitalization wereabstracted from inpatient Medication Administration Records. Theincidence of delirium will be compared to the number of subject-daysof exposure to each medication or medication class using Chi-squaretesting for univariate analysis and with generalized estimatingequations (GEE) for multivariate analysis. Classes of medications tobe analyzed include anticholinergics, antihistamines, benzodiazepines,and opiates. RESULTS: Preliminary data analysis included 209 subjects, with amedian age of 66 years (interquartile range: 58, 77). 46% of the cohortwas female. Races represented included Caucasian (74%), Black

(16%), and Asian/Pacific Islander (10%); 4% were of Hispanicethnicity. 25 subjects (12%) developed delirium while hospitalized. Ina preliminary multivariate analysis adjusting for old age (≥80), sex,race, cognitive impairment (Mini Mental Status Exam (MMSE) score<24), moderate or severe illness as rated by a nurse, and presence ofhearing or vision loss, the addition of 5 or more new medications onadmission was associated with the development of delirium (OR =3.78, p=0.018, 95% CI[1.26,11.3]). Other independent predictorsinclude old age, moderate or severe illness, and cognitive impairment. CONCLUSION: Consistent with published literature, we found theaddition of 5 or more new medications on admission predicteddevelopment of delirium during the hospital stay. Future analysis, tobe concluded by September 2011, will determine which classes ofmedication are most associated with delirium.

444. Treatment of fever during the acute stroke period at aprimary stroke center. Ashley H. Cribb, Pharm., D., student1, DianaK. Houng, Pharm.D.1, Jody L. Rocker, Pharm.D.2, Jeffrey Switzer,D.O.2, David Hess, M.D.2, Susan C. Fagan, Pharm.D.3; (1)Universityof Georgia College of Pharmacy, Augusta, GA; (2)Georgia HealthSciences University, Augusta, GA; (3)Program in Clinical andExperimental Therapeutics University of Georgia College ofPharmacy Charlie Norwood VA Medical Center, Augusta, GA PURPOSE: Fever during the acute stroke period is common(40–60%) and is associated with poor neurological outcomes.However, the use of antipyretic therapy for defervescence andimprovement of neurological outcomes is controversial. The objectiveof this study was to determine the incidence of fever in our populationand to investigate the prescribing patterns of antipyretics andantibiotics. METHODS: The study included 117 consecutive patients admitted tothe Primary Stroke Center with a diagnosis of ischemic stroke or TIAbetween January 1st – June 30th, 2010. Data was collected on patientdemographics, incidence and time of fever, and prescription ofacetaminophen and antibiotics during hospital stay. Fever was definedas a temperature greater than 38°C. RESULTS: Of the 117 charts reviewed, fifty-five patients (47%)received acetaminophen for either pain or fever. Seventeen of the 117patients were febrile during inpatient stay (average temperature,38.5°C), and sixteen of the febrile patients (94.1%) receivedacetaminophen. Thirteen (81.3%) of the febrile patients had reductionsin fever occurring on average within three days of acetaminopheninitiation. Of the 117 patients, microbiology cultures were drawn inthirty-six patients (30.8%). Thirteen of these were febrile patients, andeight (61.5%) febrile cultures showed growth. A total of twenty-threepatients (19.7%) received antibiotic therapy. Of these, twelve werefebrile patients receiving therapy for a positive culture or risk ofaspiration or ventilator-associated pneumonia. Among the 117patients, the average total acetaminophen dose administered duringinpatient stay was 4.8 grams. Acetaminophen was prescribed alone inthirty-two patients (58.1%) and in combination with ibuprofen orcodeine derivatives in twenty-three patients (41.9%). CONCLUSION: Acetaminophen use is common in acute strokepatients, especially in the presence of fever. Guidelines for the use ofacetaminophen in this setting are needed. Further data analysis iscurrently pending.

Oncology

445. Effects of mobilization regimens on the incidence of tumorcell contamination of the hematopoietic stem cells in breast cancerpatients undergoing peripheral blood stem cell transplantation.Sora Choi, B.S., Meghana V. Trivedi, Pharm.D., Ph.D.; University ofHouston College of Pharmacy, Houston, TX PURPOSE: Tumor cell contamination (TCC) of hematopoietic stemcells has been shown to confer poor prognosis in breast cancer (BC)patients undergoing peripheral blood stem cell transplantation(PBSCT). It is not clear what influence various stem cell mobilizationregimens have on the incidence of TCC. We performed a systematicreview of published data to examine the effects of mobilizationregiment on TCC of hematopoietic stem cells in BC patientsundergoing PBSCT. METHODS: Inclusion criteria were prospective and retrospective


studies reporting the TCC of hematopoietic stem cells obtained fromany stage or subtype of BC patients. Twenty-two articles (n= 2529)were included in the final analysis. Patients were divided into groupsbased on mobilization regimen (cytokines alone, cytokines +chemotherapy, chemotherapy only) and detection of TCC in anycollection (yes or no) (Table-1). RESULTS: We found that the proportion of patients with TCC ofhematopoietic stem cells after receiving cytokines only (20.6%) wassignificantly higher (p=0.01, c2 test) as compared to that afterreceiving cytokines + chemotherapy (16.7%) or chemotherapy alone(8.5%) When studies using only G-CSF as a cytokine were considered(n = 1414), the difference was still statistically significant (p=0.01, c2

test). CONCLUSION: Our results show that cytokines only (i.e., G-CSF)as a mobilization regimen may increase TCC of hematopoietic cells,possibly by stimulating the proliferation of BC stem cells and/orincreasing the mobilization of tumor cells. Since TCC is linked toincreased relapse, our systematic review provides correlative evidenceto support the role of cytokines (G-CSF) in increasing the risk ofrelapse in BC patients undergoing PBSCT. Table 1. BC patients undergoing PBSCT based on mobilizationregimen and detection of TCC in the apheresis products.

Cytokines Cytokines + Chemotherapy

only Chemotherapy only

TCC + 329 156 8

TCC - 1267 777 86

446. Acneiform rash does not predict response to neoadjuvantlapatinib monotherapy in breast cancer patients. Jennifer M.Parma, B.S.1, Anne C. Pavlick, B.S.2, Jenny C.N. Chang, M.B.B.Ch.2,Mothaffar F. Rimawi, M.D.2, Meghana V. Trivedi, Pharm.D., Ph.D.1;(1)University of Houston College of Pharmacy, Houston, TX;(2)Baylor College of Medicine, Houston, TX PURPOSE: rash is a common toxicity, occurring in more than 30%of patients receiving lapatinib, a dual inhibitor of EGFR and HER2,for the treatment of HER2-positive breast cancer. rash is a classadverse effect of drugs that target EGFR and has been associated withsuperior treatment response. However, this association between rashand response has never been shown for lapatinib in breast cancerpatients. In this study, we hypothesized that breast cancer patients whodevelop rash on lapatinib treatment will have a better response. METHODS: We prospectively enrolled 49 patients with locallyadvanced (≥ 3 cm) HER2-positive breast cancer on a clinical trial ofneoadjuvant monotherapy with lapatinib (1500 mg per day for 6weeks). Patients were followed for incidence of rash and diarrhea,which was graded using NCI CTCAE criteria. Primary endpoint of thetrial was overall response rate, assessed by objective tumormeasurements and defined by at least 50% reduction in the product ofthe largest perpendicular diameters of the breast lesion according tostandard WHO criteria. RESULTS: Forty-seven patients were evaluated and divided into fourgroups based on rash (Y/N) and response (Y/N) (Table 1). We foundthat the proportion of responders among patients with rash was notsignificantly different from that among patients who did not developrash (p=0.75, Fisher’s exact test) (Table 1). Similarly, the incidence ofdiarrhea was not significantly different in relation to the response inthese patients. CONCLUSION: In our study, incidence of rash and diarrhea did notpredict clinical efficacy with neoadjuvant lapatinib monotherapy intreatment-naïve locally advanced HER2-positive breast cancerpatients.

Response (Y) Response (N) Rash (Y) 19 (73%) 7 (27%) Rash (N) 14 (67%) 7 (33%)

447. Effectiveness of palonosetron compared with the otherserotonin antagonists in combination with aprepitant inpreventing highly emetogenic chemotherapy induced emesis.Boyoon Choi, Ph.D. Candidate1, Dong Eun Lee, B.S.1, Kyung ImKim, Ph.D. Candidate1, Hye Suk Lee, M.S.2, Hyunah Kim, Pharm.D.1,Wan Gyoon Shin, Pharm.D., Ph.D.1, Jung Mi Oh, Pharm.D.1;(1)College of Pharmacy, Seoul National University, Seoul, South

Korea; (2)Department of Pharmacy, Seoul National UniversityHospital, Seoul, South Korea PURPOSE: Palonosetron, a 2nd generation of serotonin (5-HT3)antagonist is known to be superior to the other 5-HT3 antagonists inpreventing delayed emesis in patients receiving moderatelyemetogenic chemotherapy. This study compared the effectiveness ofpalonosetron to the other 5-HT3 antagonists in preventing highlyemetogenic chemotherapy (HEC) induced emesis when administeredwith aprepitant and corticosteroids. METHODS: This institutional review board (IRB) approved studyretrospectively reviewed medical records of patients admitted to atertiary teaching hospital and received HEC between April 2008 andFebruary 2011. Patients’ medical history, drugs administered and in-hospital course during the first day (for acute emesis analysis) andfour subsequent days (for delayed emesis analysis) of chemotherapywere documented respectively. Primary endpoint was completeresponse (CR) rate and secondary endpoint was complete control (CC)rate, nausea and vomiting incidence, use of rescue medicine andparenteral nutrition, and time to treatment failure (TTF). RESULTS: A total of 157 patients (87 patients in palonosetron group,70 patients in control group) were included. Baseline characteristics inthe two groups were similar. There was no significant differencebetween the two groups neither in CR rate (acute 89.7% vs 82.9%,p=0.214; delayed 57.5% vs 57.1%, p=0.967; total period 56.3% vs48.6%, p=0.334) nor CC rate (acute 89.5% vs 81.2%, p=0.138;delayed 55.8% vs 55.1%, p=0.926; total period 55.3% vs 46.4%,p=0.271). The only significant difference between the two groups wasin the incidence of nausea in favour of palonosetron (42.5% vs 55.6%,p=0.046). CONCLUSION: This study results did not show a significantadvantage of palonosetron versus the other 5-HT3 antagonists inpreventing HEC induced emesis in combination with aprepitant. Sincethis was the first study comparing the effectiveness of palonosetronversus the other 5-HT3 antagonists in combination with aprepitant,further randomized prospective studies are warranted.

448. Evaluation of obesity on achieving remission followinginduction therapy for acute myelogenous leukemia. Laura LeighStoudenmire, Pharm.D. Candidate1, Morgan Trepte, Pharm.D.Candidate1, Katerina Katsanevas, Pharm.D.1, Courtney McCracken,M.S. Candidate2, David L. DeRemer, Pharm.D., BCOP1; (1)Universityof Georgia College of Pharmacy and Georgia Health Sciences HealthSystem, Augusta, GA; (2)Georgia Health Sciences UniversityDepartment of Statistics, Augusta, GA PURPOSE: To evaluate efficacy and toxicity in obese and non-obeseacute myelogenous leukemia (AML) patients who receive standardinduction therapy. Obesity was defined using the WHO’s criteria of abody mass index (BMI) ≥ 30. Further, to evaluate the outcomes ofanthracycline dose capping for patients with a body surface area(BSA) > 2 m2. METHODS: Retrospective analysis of AML patients who receivedstandard induction therapy at Medical College of Georgia Healthbetween 2006 and 2011. The primary endpoint was to evaluatecomplete remission (CR) rates in obese and non-obese patients asdefined by BMI. Secondary endpoints included evaluating differencesin ejection fraction changes, hospitalization days, and neutropenicfever antibiotic duration. All statistical analyses were performed usingSAS 9.2 for Windows (SAS Institute Inc., Cary, NC, 2009). RESULTS: In this interim analysis, 70 patients were evaluated. Themedian BMI of study subjects was 28.6, and 41.4% had a BMI ≥ 30.No statistical association was found between BMI category and day14 CR rates (P=0.0569), but trended to favor obese patients. Patientswith younger age (P=0.05), Caucasian ethnicity (P=0.04), or favorablecytogenetics (P=0.0004) favored achieving a CR. Nineteen patientswere identified with a BSA (>2 m2); 9 of these patients received acapped dose which did not correlate to poorer outcomes (P=1.0).There was no correlation with BMI on cardiac toxicity, hospitalizationdays (P=0.2640), or antibiotic duration (P=0.3549). CONCLUSIONS: Patients with BMI ≥ 30 trended to favor obtainingremission. Younger age, Caucasian ethnicity, and favorablecytogenetics demonstrated higher CR rates. Anthracycline dosecapping did not influence outcomes.

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Other

449. Pharmacists’ role in evaluation of “as necessary” medicationsat a community hospital. Christine E. Puschak, Pharm.D.,Candidate, Jill A. Rebuck, Pharm.D., FCCP, FCCM, BCPS; LancasterGeneral Health, Lancaster, PA PURPOSE: As necessary (PRN) medications are frequentlyprescribed in the hospital setting from standard order sets based onconvenience, regardless of whether they are administered. Ourpurpose was to characterize PRN medication ordering andadministration practices. METHODS: A one-time prospective evaluation of PRN medicationorders for all patients hospitalized at a 640-bed community hospitalwas performed. Subsequently, pharmacists ordered an automaticdiscontinuation per protocol of unnecessary PRN medications meetingcriteria for non-essential status from standard order sets if they werenot administered in the previous 48 hours (excluded:inhalers/nebulizers, electrolyte supplementation, delirium agents,emergent/rescue therapies, or antihypertensives). Nurses wereinstructed to contact pharmacy to restart any discontinued medicationsif required for patient care needs. Any patient safety concerns werealso assessed. RESULTS: Of the 10,295 total medication entries evaluated, 1,935PRN medications were identified, representing 18.8% of allmedication orders. Focusing on PRN medications from order sets,1,092 medications met criteria. Excluded were 844 (43.6%)individualized medication orders. An additional 394 medications(20.3%) were excluded from automatic discontinuation:emergent/rescue medication (164), medications administered withinthe past 48 hours (122), less than 48 hours since ordered (85), andother (23). Overall, 513 medications met criteria for automaticdiscontinuation, representing 116 different order sets. An average of 4medications per order set were discontinued, with critical care andheart failure representing the most frequent order sets. The mostcommon discontinued medications were analgesics (122), antiemetics(82), and sedatives (80). There were no patient complications ornursing requests to restart any discontinued medications. CONCLUSION: Non-administered, non-essential PRN medicationsassociated with standard order sets were common at our hospital. Wedemonstrated a successful automatic discontinuation of criteria-basedPRN medications. Pharmacists are well-positioned to evaluate thenecessity of multiple PRN medication orders.

450. Angiogenic and vasculoprotective potential of angiotensinreceptor antagonists in the brain. Lydia Cronic, B.S.1, SaharSoliman, B.S.2, Azza El-Remessy, Ph.D.2, Susan C. Fagan, Pharm.D.3;(1)University of Georgia College of Pharmacy, Augusta, GA;(2)University of Georgia College of Pharmacy, Veteran’s AffairsMedical Center, Augusta, GA; (3)Program in Clinical andExperimental Therapeutics University of Georgia College ofPharmacy Charlie Norwood VA Medical Center Au, Augusta, GA PURPOSE: Few therapeutic agents are available to affect morbidity andmortality following stroke. Moreover, these agents are frequentlyunderutilized due to needs for timely administration, risk of adverseevents, and difficult dosing and administration. Current research hasfocused on vascular protection and angiogenesis as means of improvingfunctional outcome and promoting recovery following stroke. Recentstudies have shown that the angiotensin receptor blocker candesartanimproves outcome after experimental stroke. This investigation wasundertaken to determine: 1) whether candesartan has direct proangiogenicor vasculoprotective effects on human cerebral microvascular endothelialcells and 2) whether the direct effects are a class effect. METHODS: Human cerebral microvascular endothelial cells(HCMECs) were grown on collagen and exposed to therapeuticconcentrations of either candesartan or losartan. Angiogenic potentialwas measured through tube formation and wound healing (migration)assays. Vascular protection was measured through barrier functionintegrity using electric cell substrate impedance sensing (ECIS). RESULTS: Candesartan 0.1 µg/mL and losartan 0.05 µg/mL directlypromoted tube formation at 24 hours (7.8, 22.5, 20.25 for control,candesartan and losartan, p<0.05 n=5,6, 4 respectively). Similarly,Candesartan 0.1 µg/mL also increased migration at 18 and 24 hours(26.4 ± 1.3% and 39.0 ± 4.9% at 18 hours, p<0.05, F-ratio = 4.71; and

32.7 ± 1.1% and 45.2 ± 5.6% at 24 hours, p<0.05, F-ratio = 6.3).Similar effects were seen with losartan. Furthermore, ARB treatmentprotected against hydrogen peroxide-induced oxidative stress andpreserved barrier function of the cells. CONCLUSIONS: ARBs are proangiogenic and vascular protective inthe cerebral vasculature at clinically-relevant concentrations. This mayexplain the ability of candesartan to promote recovery afterexperimental stroke.

451. Evaluation of a potassium replacement protocol in non-ICUpatients at an urban safety net hospital. Megan E. Austin,Pharm.D.,Candidate1, Andrew Smith, Pharm.D.2, Tony Huke,Pharm.D.1; (1)Truman Medical Center, Kansas City, MO; (2)UMKCSchool of Pharmacy, Kansas City, MO PURPOSE: This study is a retrospective evaluation of theeffectiveness of a potassium replacement protocol in patients onmedical/surgical (non-ICU) units. METHODS: A retrospective case-control study was performed. Thestudy population consists of 200 patients (100 cases and 100 controls)who were admitted September 1, 2010 to March 31, 2011 to ourinstitution. Case patients were defined as having a potassiumreplacement protocol ordered and control patients didn’t have theprotocol ordered. The following information was obtained: age, sex,height and weight, serum creatinine, MDRD, race, admissiondiagnosis, index and repeat potassium level, potassium dose, route ofadministration, time from index level to replacement dose, time fromindex level to repeat potassium level, protocol deviation if present.Control patients were matched to cases in regards to gender, age andrenal function. The primary outcome of the study was the responsetime to replacement of low potassium levels. Secondary endpointsinclude effectiveness of replacement protocol (i.e., K+ ≥ 4mmol/L)and the ability of the staff to appropriately use the protocol.Comparison between data was made using student’s t-test forcontinuous variables and c2 test for nominal or ordinal items. A p-value of < 0.05 was considered statically significant. Statisticalanalysis will be performed using SPSS version 18 (SPSS, Inc.,Chicago, IL). RESULTS: Data collection on the case patients has been completed.One hundred patients had 170 episodes of hypokalemia(K+<3.5mmol/L). The average replacement dose was 60 mEq andaverage time to replacement was 386 minutes. Data collection on thecontrol patients is ongoing and will be completed prior to presentation. CONCLUSION: Not determine at time of abstract submission.

452. Assessment of recommendations made by a clinicalpharmacist in a palliative care setting: A retrospective cohortstudy. Holly L. Tumlin, Pharm.D. Candidate, LeAnn B. Norris,Pharm.D.; South Carolina College of Pharmacy-USC Campus,Columbia, SC PURPOSE: Palliative care serves are aimed at helping control notonly the symptoms of a disease, but also actively working to treat thepatient’s physiological and spiritual needs. According to the NationalHospice and Palliative Care Organization (NHPCO), in 2009 over5,000 palliative care sites were available in the United States and 1.56million people received care. Despite the growth in sites, manypalliative care services do not have a clinical pharmacist on theirinterdisciplinary team. Although documentation was seen as early asthe 1980s for the useful services a pharmacist could bring to thepalliative care team, little evidence exists of the actual benefit ofhaving a pharmacist in this setting. The purpose of this study is toprovide more data to identify the importance and benefit of includingpharmacists in the management of patients receiving palliative care. METHODS: This is a retrospective cohort study approved by theDorn VA institutional review board upon initiation. Medical records of200 patients who were over the age of 18 who were admitted to thehospice and palliative care unit at the WJB Dorn VA Hospital betweenAugust 2009 and May 2010 were reviewed for pharmacy interventionsfor inclusion in this study. A validated tool developed by Overhageand Lukes was utilized and adapted for documentation of pharmacyinterventions, the value of service, and the outcome of theintervention. Two separate health care professionals completed theassessment tool and evaluated the outcome for comparison. Theprimary outcome of this project was to capture, describe, and assess


the interventions made by the pharmacist using a scale that evaluatesthe importance and relevance of the intervention. The secondaryoutcome was the pharmacy intervention acceptance rate. Appropriatestatistical analysis will be applied to the data set. RESULTS: Research ongoing CONCLUSION: Research ongoing

Pediatrics

453. Buprenorphine withdrawal in an infant after cessation ofbreastfeeding: A case report and review of the literature. HaniElladki, Pharm.D., Candidate1, Paul Thill, Pharm.D., BCPS2; (1)FerrisState University, Dearborn Heights, MI; (2)Ferris State UniversityCollege of Pharmacy, Saginaw, MI PURPOSE: To report a case of buprenorphine withdrawal in an infantafter an abrupt cessation of breastfeeding and to review the publishedliterature on the topic. It is well known that exposure to buprenorphinein utero, can lead to neonatal abstinence syndrome (NAS). We reporthere a 4-month old infant who displayed symptoms of withdrawalapproximately 2 days after the mother stopped breastfeeding.Symptoms included frequent yawning, sneezing, pupillary dilation,agitation, sweating, hyperactive Moro reflex, myoclonic jerks, tremorsand insomnia. The mother stated that she was using buprenorphinethroughout her pregnancy and there were no signs of NAS at birth.Upon diagnosis the infant was placed on methadone and experiencedimmediate improvement of her withdrawal symptoms. Patient wasdischarged after 3 days on a methadone taper. The Naranjo scalesuggests this is a probable adverse event. METHODS: We performed a MEDLINE search (1966–May 2011)using keywords: buprenorphine, breastfeeding and withdrawal.Review articles, case reports and primary research publications wereincluded in this search. RESULTS: No case reports were found describing buprenorphinewithdrawal in infants secondary to cessation of lactation. One casereport found insignificant levels in breast milk for a child experiencingNAS. Two studies investigated buprenorphine concentrations in breastmilk and determined the concentration was unlikely to have adverseeffects on lactating infants. This case report represents an issue thathas not been discussed extensively or studied in the literature and it islikely healthcare providers do not consider it in the care of newborninfants or education of breastfeeding mothers on buprenorphine. CONCLUSION: Although buprenorphine has generally beenconsidered safe during lactation, this case report is in contrast to thatassumption. Until more evidence is published, healthcare providersshould specifically counsel lactating mothers taking buprenorphine towatch for signs of withdrawal and avoid rapid cessation ofbreastfeeding.

454. Evaluation of busulfan targeted therapy andpharmacokinetics in pediatric patients undergoing hematopoieticcell transplantation. Shirley Yan, B.S., Christopher C. Dvorak, M.D.,Lisa Musick, Pharm.D., Jason Law, M.D., Morton J. Cowan, M.D.,Biljana Horn, M.D., Janel R. Long-Boyle, Pharm.D., Ph.D.;University of California, San Francisco, San Francisco, CA PURPOSE: Busulfan is an alkylating agent routinely used in theconditioning regimens of pediatric hematopoietic cell transplantation(HCT). Identifying covariates that influence busulfan exposure isimportant for the development of better dosing strategies in HCT. Thisstudy aims to evaluate patient-specific covariates as contributors to thevariability of busulfan exposure in pediatric HCT recipients using apopulation pharmacokinetic (PK) approach, as these remain poorlydefined. METHODS: We retrospectively collected PK data from the routinetherapeutic monitoring of busulfan levels in pediatric HCT recipientsat UCSF Benioff Children’s Hospital between January 2007 andJanuary 2011. Patients were included in the analysis if they hadundergone a related or unrelated HCT including busulfan therapy,were between 0 to 18 years of age, and had busulfan time-concentration data available for analysis. Busulfan drug levels andpotential covariates influencing drug exposure will be analyzed withstandard population PK methodologies using non-linear mixed effectsmodeling software (NONMEM). RESULTS: This study will utilize busulfan time-concentration data

available in 52 pediatric HCT recipients (36 males/16 females) for atotal of 117 individual PK profiles. Subjects range in age from 1 monthto 18 years. Median weight is 20 kg (range, 3–101) and includes 10subjects with an actual body weight less than 12kg. A total of 785quantifiable concentrations are available for PK modeling. The range ofobserved busulfan concentrations is 0–3163 ng/mL. Forty-three subjects(83%) had intensive PK performed on more than one occasion. CONCLUSION: Data collection is complete. PK analysis will becompleted and results available at the time of the ACCP AnnualMeeting.

455. A retrospective descriptive study of combination antifungaltherapies in pediatric oncology patients. Whitney L. Davis,Pharm.D. Candidate, William L. Greene, Pharm.D., Jerry L. Shenep,M.D., Randal T. Hayden, M.D., Brandon M. Triplett, M.D.; St. JudeChildren’s Research Hospital, Memphis, TN PURPOSE: Invasive fungal infections are a major cause of mortalityand morbidity in immunocompromised patients such as those treatedat St. Jude Children’s Research Hospital. Though they have not beenadequately evaluated in clinical trials, combination antifungaltherapies are sometimes used to treat invasive fungal infections. Therisk-to-benefit profile of antifungal therapies is unknown as they aremore expensive than monotherapies and potentially more toxic. Thisstudy is an observational description of combination antifungaltherapy administered to pediatric and adolescent oncology patients.Our goal is to identify practices which vary from currently publishedtreatment guidelines, and to stimulate further study and performanceimprovement efforts involving treatment of these patients. METHODS: We will conduct a retrospective chart review using anelectronic medical record system. All medical records reflecting anadmission between February 2006 and June 2011 during which apatient received concurrent therapy with two or more systemicantifungal drugs for more than 48 hours will be evaluated. Specificdrug combinations, drug class combinations, dosages, routes,frequencies, durations of therapy, and serum concentrations will bedescribed as well as perceived toxicities and breakthrough infections. RESULTS: Initial review of the electronic medical record systemshows 137 patients receiving combination antifungal therapy as it hasbeen defined for this study. While most patients received one instanceof combination antifungal therapy there are some patients thatreceived multiple regimens involving different antifungal agents.Thorough data analysis will be completed by October 2011. CONCLUSION: Combination antifungal therapy is utilized inclinical practice at St. Jude Children’s Hospital. More definitiveconclusions characterizing this practice will be available by October2011.

456. Improved safety of intermittent infusion delivery in theneonatal intensive care unit: establishing a need for thestandardization of medication administration. Amy Mitchell,Pharm.D., Candidate1, Thomas Young, M.D.2, Nancy Gary, RN2,Angela Peake, Pharm.D.2, Rhonda Zillmer, Pharm.D.2, Laura Hayn,Pharm.D., BCPS2; (1)Campbell University College of Pharmacy andHealth Sciences, Buies Creek, NC; (2)WakeMed Health andHospitals, Raleigh, NC PURPOSE: Variations in medication administration can result inincomplete medication delivery, inappropriately rapid infusion times,and/or administration of excessive fluid volumes. This study is aninterdisciplinary quality improvement project involving pharmacy,nursing and medicine that includes standardization of the medicationadministration process along with infusion and flush time practice in aneonatal intensive care unit (NICU). METHODS: This study assessed variability in practice of druginfusion times, flush infusion times, and flush infusion volumes in aNICU via a voluntary, anonymous survey of nursing staff. Three drugsthat require different infusion and flush times were used in the survey:ampicillin (slow push), gentamicin (30 minutes) and vancomycin (60minutes). The nurses listed their current practice of drug infusiontimes, flush infusion times, and flush infusion volumes for each drugand responses were compared. RESULTS: Overall, 34 out of 93 nurses completed the survey. A totalof 33 (97%) respondents documented appropriate medication infusionrates. Only 2 (5.9%) respondents documented an appropriate flush

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time. After noting the variability of flush times, an analysis ofintermittent IV drugs commonly used in the NICU (n=72) and thevolume remaining in the tubing post infusion was performed. A list ofsafe flush times was developed. CONCLUSION: The variability of results demonstrated a need for astandard medication administration protocol. A comprehensive chartof intermittent IV drug dosing volumes, infusion volumes, andinfusion and flush times for the smallest and largest babies in theNICU was developed. The chart contributed to a standard medicationadministration protocol. The protocol has been written, and nursingeducation will take place.


457. Promoting sustainability: advocating the implementation of acommunity-based, self- managed, pharmacist-led diabetes careprogram in a coastal community in the Philippines. Marie Jett V.Cabrera, Student, Carlo Antonio G. Boado, Student, Peter F. Quilala,R.Ph., M.D.; University of Santo Tomas, Manila, Philippines PURPOSE: Diabetes mellitus is enlisted by the Department of Healthas the 8th leading cause of mortality in the Philippines. At the currentestimate of the population, this means 2.5 million Filipinos withdiabetes, with perhaps an equal number remains undiagnosed. Thisstudy was carried out to 1.) identify patients at risk for diabetes andprovide management for the disease, 2.) support the feasibility of asustainable community-based, self- managed, pharmacist-led diabetescare program in a coastal community, 3.) teach the stakeholders theprogram process through mentoring strategies, and 4.) disseminateinformation packets and conduct classroom sessions. METHODS: The program was divided into nine stations, namely,patient registration, medical history, medication history, vital signs,capillary blood glucose determination, visual acuity test, podiatricexamination, diabetes risk calculation, and medication counseling.Themed activities were also done which included nutritional strategiesand glycosylated hemoglobin determination. To promotesustainability, the second part of the project was conceptualized. It wasdivided into five phases. These were 1.) education about diabetes, 2.)establishment of the importance of knowing the HbA1c, 3.) institutionof a medication review protocol for the community, 4.), and 5.) fullview on how diabetes nutrition and physical activity seminars wereadministered respectively. To evaluate on the community’scompetence on operating the program, clinical outcomes, patient’sdemand for services, self-management behavior changes, and patientand provider’s satisfaction were obtained and measured. RESULTS: Among the 27 patients, 36% were at risk for pre-diabetesmellitus, while 8% have the disease. The study utilized two healthsurveys, SF-36 and Diabetes Related Quality of Life Survey(DRQoL). Satisfaction on 1.) Diabetes control from 16% wassignificantly raised to 84%, and 2.) Self-care regimen from 23% wassignificantly raised to 77%. CONCLUSIONS: The patients seen by the clinical pharmacist reportboth excellent diabetes-related and overall quality of life.

Pharmacoepidemiology

458. Drug-induced acute renal failure using the FDA adverseevent reporting system database. Ali Alhammad, M.S., AbdulkhaliqJ. Alsalman, M.S., Maitham A. Al Hawaj, B.S., Yousef N. Alhashem,M.S., Wally R. Smith, M.D., Spencer E. Harpe, Pharm.D., Ph.D.;Virginia Commonwealth University, Richmond, VA PURPOSE: The incidence of acute renal failure (ARF) is increasing;A substantial proportion of these cases are due to drug-inducednephrotoxicity. Data from post-marketing surveillance programs, likethe FDA Adverse Event Reporting System (AERS), can be useful inassessing the risk of an adverse drug event (ADE). Our objective is todescribe reports with ARF (cases) and reports without ARF (non-cases) and outcomes resulting from ARF using the AERS database. METHODS: Data were extracted from the AERS database from2004–2009. All reports of cases and non-cases were described andanalyzed interim of suspected drugs, health outcomes, and othercharacteristics. Descriptive statistics (frequencies and proportions) andc2 tests were used. RESULTS: The AERS data used in this study represents 2,231,689

reports from 184 countries, of which 27,190 were reports of ARF.There was approximately a two-fold increase in the percentage ofreports of ARF from 2004 to 2009 (n = 3,594; 13% to n = 6,104; 22%,respectively). Most reports were submitted by manufacturers (cases =89%, non-cases= XX%). The majority of reports were for infants(cases = 75%, non-cases = 57%). In cases, drugs were the primarysuspect, the secondary suspect and concomitant in 18%, 14% and 66%of reports, respectively. The five drugs with the highest reportedfrequencies of ARF were rofecoxib, valacyclovir, metformin,simvastatin, and digoxin. Unfavorable outcomes were more likely tooccur in cases than non-cases (death 24% vs. 12%, life threateningcondition 21% vs. 5%, initial or prolonged hospitalization 76% vs.33%, disability 6% vs. 4% and required intervention 4% vs. 2%; p-value < 0.001, for all comparisons). CONCLUSIONS: These preliminary findings present an overallpicture of reports with ARF. These findings can be informative forregulatory authorities and healthcare professionals. Additionalanalyses with reporting odd ratios (ROR) are needed to support theseinitial findings.


459. Association between the CYP2C9*8 variant and warfarinclearance in African Americans. Katarzyna Drozda, Pharm.D.Candidate1, Harumi Takahashi, Ph.D.2, Shitalben R. Patel, M.S.1,Nancy L. Shapiro, Pharm.D., BCPS1, Edith A. Nutescu, Pharm.D.1,Larisa H. Cavallari, Pharm.D.1; (1)University of Illinois at ChicagoCollege of Pharmacy, Chicago, IL; (2)Meiji PharmaceuticalUniversity, Tokyo, Japan PURPOSE: S-warfarin is metabolized by the polymorphic CYP2C9enzyme. The CYP2C9 R150H (*8) allele is common (frequency of0.07) and associated with lower warfarin dose requirements in AfricanAmericans. However, there are limited data on its functional effects.We sought to determine the impact of the CYP2C9*8 allele onmetabolic clearance of warfarin. METHODS: A genetic sample and data were obtained from 38African Americans on a stable warfarin dose. Genotype wasdetermined by pyrosequencing or capillary sequencing. S- and R-warfarin steady-state plasma concentrations (Css); oral, unboundclearance (Clpo,u) of S-warfarin; oral clearance (Clpo) of R-warfarin;and S- to R-warfarin ratio were determined by HPLC and comparedbetween CYP2C9*1 homozygotes (n=26) and *8 carriers (n=12). RESULTS: Data are shown in the table. Consistent with previousdata, warfarin dose requirements are 27% lower with the *8 allele. Asexpected, R-warfarin clearance was similar between genotype groups.However, Clpo,u of S-warfarin was reduced by 30%, and S- to R-warfarin Css was increased by 31% with the CYP2C9*8 allele versusthe CYP2C9*1/*1 genotype. CONCLUSION: Our results support decreased S-warfarin clearanceas the mechanism underlying lower warfarin dose requirement withCYP2C9*8 allele. Table 1.

*1/*8 or*1/*1 (n=26) *8/*8 (n=12) p value

Warfarin (mg/d) 7.4 ± 3.2 5.4 ± 1.9 0.02Clpo (ml/min/m2) 0.94 ± 0.27 0.90 ± 0.22 NSClpo,u (ml/min/m2) 122 ± 66 85 ± 27 0.02Cp 0.65 ± 0.22 0.85 ± 0.27 0.02Mean ± SD

461. Breast cancer patient understanding and knowledge ofpharmacogenomic testing in Lineberger Comprehensive CancerCenter trial 0801. Andrea N. Yuen, Pharm.D. Candidate1, Jeffrey M.Peppercorn, M.D.2, Lynn G. Dressler, Dr.PH.3, Wing K. Chiu, M.S.4,Christine M. Walko, Pharm.D.1, Peter Rubin, M.D.5, Oludamilola A.Olajide, M.D.6, Rachel E. Raab, M.D.7, Daniel Carrizosa, M.D.8,Steven W. Corso, M.D.9, Garry Schwartz, M.D.10, Howard L. McLeod,Pharm.D.3, Lisa A. Carey, M.D.4, William J. Irvin Jr., M.D.4;(1)University of North Carolina (UNC) Eshelman School ofPharmacy, Chapel Hill, NC; (2)Duke University, Durham, NC;(3)UNC Institute of Pharmacogenomics and Individualized Therapy,Chapel Hill, NC; (4)UNC Lineberger Comprehensive Cancer Center(LCCC), Chapel Hill, NC; (5)Moses Cone Regional Cancer Center,


Greensboro, NC; (6)Rex Hematology/Oncology Associates, Raleigh,NC; (7)East Carolina University, Greenville, NC; (8)CarolinasMedical Center, Charlotte, NC; (9)Palmetto Hematology/Oncology,Spartanburg, SC; (10)Northeast Oncology Associates, Concord, NC PURPOSE: As pharmacogenomic research becomes more prevalent,it is important to assess the motivation and understanding of trialparticipants to assess areas for improvement in informed consent. Thisstudy was conducted to examine these issues in patients participatingin a pharmacogenomic trial. METHODS: We conducted surveys described below among patientsenrolled in a prospective study of CYP2D6 genotype-guidedtamoxifen therapy for breast cancer. This trial evaluated changes inendoxifen concentrations among patients with dysfunctional CYP2D6alleles who received an increased dose of tamoxifen. At the time ofconsent, participants completed a 25 item paper survey addressinggenetic knowledge (T/F statements), the trial’s purpose (5 point LikertScale responses) and reasons for their participation (check all thatapply). Descriptive statistics were provided for all responses. RESULTS: 99% (376/382) completed the survey. The top threereasons for participating in this trial was: to help other breast cancerpatients (82%); to help their physician understand the best way totreat their cancer (80%); and wanting a genetic test to show how theirbody uses tamoxifen (71%). 85% correctly answered at least 5/8 of thegenetic knowledge questions. Although 96% agreed that the trial’spurpose was to identify how different people respond to tamoxifen,nearly 33% also believed that its’ purpose was to study the inheritednature of breast cancer. Even though the informed consent stressedlack of direct patient benefit, 72% believed that the trial would helpthem directly. CONCLUSION: Despite a general understanding of genetics, asubstantial percentage of participants demonstrated confusionregarding the trial’s purpose. Participants misunderstood the nature ofthe research, potential for direct personal benefit, and the role of thetrial as a means to gain access to a test that was commerciallyavailable. These findings highlight considerable room forimprovement in patient education in pharmacogenomic trials.

462. The association between NF-kB gene polymorphisms andallograft survival in the Hispanic kidney transplant population.Eunah Cho, Pharm.D., Candidate1, David Min, Pharm.D1, Ian V.Hutchinson, Ph.D.2; (1)Western University of Health Sciences,College of Pharmacy, Pomona, CA; (2)USC School of Pharmacy, LosAngeles, CA

PURPOSE: NF-ҡB is an essential transcription factor involved incellular responses to stimuli such as cytokines, which play a key rolein regulating the immune and inflammatory response during allograftrejection. The objectives of this study are: 1) to examine the NF-ҡBgene polymorphism in relation to risk of graft failure, and 2) toevaluate the risk factors of graft failure in renal allograft recipients. METHODS: A total of 690 Hispanic patients who received kidneyallograft between 2001 and 2010 at St. Vincent Medical Center wereretrospectively evaluated. Graft survival time and other risk factorswere obtained through TranTrak®; NF-ҡB polymorphism (NF-ҡB 1,NF-ҡB 2 and NF-ҡB inducing kinase) was genotyped using the Tag-Man-PCR method. All analyses were performed using SPSS version14.0 (SPSS). The cumulative probability and associated factors ofgraft survival time, rejection, and graft failure were obtained throughthe Kaplan and Meier model and Cox regression analysis. RESULTS: The primary outcome regarding NF-kB polymorphism inrelation to risk of graft failure is currently being processed. Theclinical data collection for the secondary outcome regarding the riskfactors of graft failure has been completed. At multivariable Coxregression analysis, creatinine at one year (P<0.001; HR 3.58),cadaver donor (P<0.001; HR 1.45), diabetes (P=0.009; HR 1.48),delayed graft function (P=0.022; HR 1.43) were associated with thegraft survival time, rate of rejection, and graft loss. CONCLUSION: The associated predictors of graft survival time inthe Hispanic renal allograft recipients were evaluated. However, thecontribution of NF-ҡB polymorphisms to graft survival time alongwith the above risk factors is still currently being analyzed, and theconclusion of the study will be presented once completed.

463. Effects of CYP2D6*10/*10 genotype on the pharmacokineticsof metoclopramide. Hye-In Lee, M.S.1, Chang-Ik Choi, M.S.1, Jung-Woo Bae, Ph.D.2, Choon-Gon Jang, Ph.D.1, Seok-Yong Lee, Ph.D.1;(1)School of Pharmacy, Sungkyunkwan University, Suwon,Gyeonggido, South Korea; (2)College of Pharmacy, KeimyungUniversity, Daegu, South Korea PURPOSE: Metoclopramide, a dopamine D2 receptor antagonist, isused as an antiemetic agent. Metoclopramide is mainly metabolizedvia monodeethylation, which is primarily mediated by CYP2D6isozyme. We investigated the effects of CYP2D6 geneticpolymorphism on the pharmacokinetics of metoclopramide. METHODS: Eighteen subjects were selected and they were dividedinto two different groups according to CYP2D6 genotype,CYP2D6*1/*1 (n=10) and CYP2D6*10/*10 (n=8). After overnightfasting, each subject received a 10 mg oral dose of metoclopramide.Blood samples were collected up to 24 hr after drug intake, andplasma concentrations of metoclopramide were determined byvalidated HPLC-MS/MS method. RESULTS: Cmax and AUCinf of metoclopramide in CYP2D6*10/*10were 1.5- and 2.1-fold higher than those in CYP2D6*1/*1 (P<0.01 andP<0.001, respectively). AUCinf of metoclopramide in CYP2D6*1/*1and CYP2D6*10/*10 was 161.6 ± 41.1 ng·hr/mL and 341.8 ± 68.2ng·hr/mL, respectively. Oral clearance of metoclopramide inCYP2D6*10/*10 was 53% lower than that in CYP2D6*1/*1(P<0.001). CONCLUSION: CYP2D6*10 allele is found to affect thepharmacokinetics of metoclopramide.

464. CYP2D6*10/*10 genotype significantly affected thepharmacokinetics of tamsulosin. Hye-In Lee, M.S.1, Chang-Ik Choi,M.S.1, Jung-Woo Bae, Ph.D.2, Choon-Gon Jang, Ph.D.1, Seok-YongLee, Ph.D.1; (1)School of Pharmacy, Sungkyunkwan University,Suwon, Gyeonggido, South Korea; (2)College of Pharmacy,Keimyung University, Daegu, South Korea PURPOSE: Tamsulosin, an antagonist of α1A adrenoceptors in theprostate, is indicated for treatment of the signs and symptoms ofbenign prostatic hyperplasia. Tamsulosin is extensively metabolized,mainly by CYP3A4 and CYP2D6. The CYP2D6*10 allele, leading toa very unstable enzyme with abnormal folding and reduced substrateaffinity, is found with higher frequency in Asian populations. Weinvestigated the effects of CYP2D6*10/*10 genotype on thepharmacokinetics of tamsulosin. METHODS: Sixteen subjects were selected and they were dividedinto two different groups according to CYP2D6 genotype,CYP2D6*1/*1 (n=8) and CYP2D6*10/*10 (n=8). After overnightfasting, each subject received a 0.2 mg oral dose of tamsulosin. Bloodsamples were collected up to 48 hr after drug intake, and plasmaconcentrations of tamsulosin were determined by validated HPLC-MS/MS method. RESULTS: Cmax and AUCinf of tamsulosin in CYP2D6*10/*10 were1.6- and 1.9-fold higher than those in CYP2D6*1/*1 (P<0.01 andP<0.001, respectively). AUCinf of tamsulosin in CYP2D6*1/*1 andCYP2D6*10/*10 was 43.0 ± 9.6 ng·hr/mL and 81.0 ± 12.2 ng·hr/mL,respectively. Oral clearance of tamsulosin in CYP2D6*10/*10 was52% lower than that in CYP2D6*1/*1 (P<0.001). CONCLUSION: CYP2D6*10 allele has significant impact on thepharmacokinetics of tamsulosin.

465. Effect of CYP2D6*10 allele on the pharmacokinetics ofpropranolol in Koreans. Hye-In Lee, M.S.1, Chang-Ik Choi, M.S.1,Jung-Woo Bae, Ph.D.2, Choon-Gon Jang, Ph.D.1, Seok-Yong Lee,Ph.D.1; (1)School of Pharmacy, Sungkyunkwan University, Suwon,Gyeonggido, South Korea; (2)College of Pharmacy, KeimyungUniversity, Daegu, South Korea PURPOSE: Propranolol is a non-selective b-adrenergic blockingagent used in the treatment of hypertension, angina pectoris andcardiac arrhythmias. The major metabolic pathway of propranolol, 4-hydroxylation, is mediated by polymorphic CYP2D6. We studied toevaluate the effects of major polymorphism of the CYP2D6*10 onpharmacokinetics of propranolol. METHODS: A 40-mg oral dose of propranolol was given to Koreanvolunteers with different CYP2D6 genotype. Propranolol wasanalyzed by HPLC-fluorescence in plasma samples collected up to 24

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hour after drug intake. RESULTS: Pharmacokinetic parameters of propranolol weresignificantly different between subjects with homozygous CYP2D6*1allele and those heterozygous for the CYP2D6*10 and homozygousCYP2D6*10 allele. In subjects heterozygous and homozygous for theCYP2D6*10 allele, Cmax and AUC0-∞ of propranolol were greater, oralclearance was lower than those in homozygous CYP2D6*1 subjects. CONCLUSION: The CYP2D6*10 allele was shown to be associatedwith decreased metabolism of propranolol.


466. Characterization of polymyxin B (PB) against Acinetobacterbaumannii using pharmacokinetic and pharmacodynamic(PK/PD) approaches. Marie San Roman, Pharm.D. Candidate1,Brian T. Tsuji, Pharm.D.2; (1)University at Buffalo, Buffalo, NY;(2)Laboratory for Antimicrobial Pharmacodynamics University atBuffalo, State University of New York, Buffalo, NY PURPOSE: Infections caused by A. have become increasinglyresistant to current therapeutic options, leading clinicians to utilize lastline therapeutic options such as PB. The objective of this study was tocharacterize killing and define the PK/PD profile of PB against A. . METHODS: A. ATCC 19606 was utilized at inoculums of 106

CFU/mL and 108 CFU/mL against varying concentrations of PB (0.5,1, 2, 4, 8, 16, 32 and 64 mg/L) using a static time kill experiment withsampling time points at 0, 0.5, 1, 2, 4, 6, 8, 24, 26, 28, 30, 32 and 48hour. Pharmacodynamic analysis was performed by fitting data to aHill type mathematical model to compare pharmacodynamicparameters [Equation: E=E0-(-C^H)EC50^H+C^H)]. RESULTS: PB was rapidly bactericidal against a 106 inoculum of A.at 1mg/L to 64 mg/L, with a log decrease respectively, by 8 hr. Atconcentrations below 4 mg/L, there was regrowth by 48 hr versuscomplete bacterial eradication with concentrations above 4 mg/L. At108 CFU/mL, PB killing was attenuated at concentrations below 16mg/L, with little change seen in bacterial counts. At a concentration of32 mg/L, an initial log decrease of 5.96 was seen in the first 8 hours,with subsequent regrowth. At a concentration of 64 mg/L, completebacterial eradication was seen by 8 hours. A Hill type modelcharacterized the PK/PD data well (R2 > 0.9), with changes in thefollowing parameters at 106/108 CFU/mL: : 4.1/3.2, EC50: 5.9/21.6,H: 4.2/2.3. CONCLUSIONS: PB killing was rapid at a lower inoculum of 106

over the first 8 hours, with regrowth seen in concentrations below 4mg/L. At a higher inoculum, the killing of A. by PB is attenuated,with little change in bacterial count noted for most clinically relevantconcentrations, which may have implications for the treatment of highdensity infections.

467. Attenuation of vancomycin pharmacodynamics (PD) due todense inoculum methicillin-resistant Staphylococcus aureus(MRSA). Curtis Johnston, Pharm.D. Candidate, 2012, Brian T. Tsuji,Pharm.D.; Laboratory for Antimicrobial PharmacodynamicsUniversity at Buffalo, State University of New York, Buffalo, NY PURPOSE: Emergence of vancomycin heteroresistant sub-populations plays a significant role in treatment failure of METHODS: A community acquired isolate (MRSA PFGE typeUSA300) was used in all experiments. Time kill experiments wereconducted over 48 hr for three different inoculums (104, 106, 108

colony forming units (CFU)/, and using non-linear regression a four-parameter concentration-effect Hill-type model was fitted to the effectparameter using the equation: E=E0-[(Emax*xH)/(EC50H+xH)]. RESULTS: At high (108 CFU/inoculums of MRSA, the bactericidalactivity of vancomycin was significantly attenuated. Simulatingclinically relevant vancomycin trough concentrations of 16 mg/L, thefollowing log changes in bacterial counts were seen at 48 ht for theinitial inoculums of 108/106/104 CFU/: 0.1/-2.8/-4.2 log10 CFU/.Although greater reductions in bacterial counts were seen at lowerstarting inoculums, no killing was seen at 48 hr regardless of startinginoculum for any concentration below 16 mg/L. PK/PD analysisrevealed significant differences across the following parametersrepresenting decreases in bactericidal activity with increasing initialCFU/ml):

CONCLUSION: High initial inoculum MRSA attenuated thebactericidal activity of vancomycin. These results have significantclinical implications regarding the utility of vancomycin in highdensity infections: aggressive exposure (AUC/MIC) profiles may benecessary for vancomycin monotherapy or combinations/alternativeagents should be considered.

Psychiatry

468. Blue genes: genetic variant of brain-derived neurotrophicfactor associated with depression index in post-coronary arterybypass graft patients. Diana N. Pinchevsky, Pharm.D., IndraniHalder, Ph.D., Bea Herbeck Belnap, Dr.Biol.Hum., Bruce L. Rollman,M.D., M.P.H., Robert E. Ferrell, Ph.D., Tanya J. Fabian, Pharm.D.,Ph.D., BCPP; University of Pittsburgh, Pittsburgh, PA PURPOSE: Depression and cardiovascular disease are often METHODS: Mouthwash samples were collected from 237 of 453depressed and non-depressed patients enrolled in the RESULTS: Minor allele frequency of BDNF rs6265 was 18% andallelic distribution of BDNF genotypes was within Hardy-Weinbergequilibrium, X2 = 0.094 p value = 0.76. The GG genotype at rs6265was more commonly associated with depression defined by a score of>9 on the PHQ-9, X2 = 3.02 p value = 0.08, especially in women, X2 =4.94 p value = 0.03. The DISH scores, used as a continuous measureof depression severity, were also associated with the GG genotype, p-value = 0.02. CONCLUSION: In post-CABG patients, vulnerability to depressionand depressive symptom severity are associated with the rs6265 GGgenotype, while the A allele appears to be protective. This effect isparticularly apparent in women. These findings warrant furthervalidation and exploration of BDNF in relation to the disease state.Depression in cardiovascular disease is complex and geneticvariability of BDNF may be a contributing component and a potentialtreatment target.

Substance Abuse/Toxicology

469. Benzodiazepine use in alcohol withdrawal syndrome at anacademic medical center. Kyle A. Amelung, Pharm.D. Candidate2012, Eli N. Deal, Pharm.D., BCPS; Barnes-Jewish Hospital, St.Louis, MO PURPOSE: This retrospective review was completed to assesspractices in managing alcohol withdrawal syndrome (AWS) at a 1300-bed tertiary academic medical center. METHODS: Medical records were reviewed on 100 randomly-selected patients admitted between January 1 and June 30, 2010 withan ICD-9 code for alcohol use/abuse and an active benzodiazepine(BZD) order for at least 24 hours. Patients were excluded if BZD usewas for sedation or non-alcohol withdrawal related anxiety.Documented information included demographic and admissioninformation, past medical history, ethanol level upon admission,utilization of an AWS order set, alcohol withdrawal medicationregimen (agent, route, and fixed-schedule or symptom-triggereddosing), and total amount of BZD administered over the length of stay. RESULTS: The average patient was a 48-year old male whoconsumed 10.6 drinks per day. Approximately one-third of patientshad a history of AWS with 15% having a noted history of seizuresrelated to alcohol withdrawal. One-third had a measurable ethanollevel upon admission with the mean being 233 mg/. The majority ofpatients were admitted to the medicine service (82%). An alcoholwithdrawal order set was utilized in 45% of all patients. Overall, afixed-regimen was chosen in 50% of cases and a symptom-triggeredregimen was chosen in 87% of cases. The mean total amount of(lorazepam-equivalent) BZDs administered was 16.6 milligrams overan average length of stay of 5.4 days. When only fixed-scheduleorders were written (n=12), the total amount of medicationadministered was 27.4 milligrams. When only symptom-triggeredorders were written (n=50), the total amount of medicationadministered was 3 milligrams. CONCLUSIONS: The BZD prescribing practices for AWS at thisinstitution are varied. This could be due to a number of factorsincluding extensive patient differences, the high number of prescribingphysicians, and the lack of standardized assessments for symptoms of


alcohol withdrawal.


470. Effectiveness and safety of influenza vaccine in first sixmonths post-lung transplant. Kalynn A. Rohde, Student, John J.M.Moran, B.S., Mary S. Hayney, Pharm.D., M.P.H.; University ofWisconsin School of Pharmacy, Madison, WI PURPOSE: Clinicians may be reluctant to administer influenzavaccine to the recently transplanted because of hypothesized lowimmune responses and the possibility of inducing acute rejection.Because the influenza vaccine changes annually, all patients must beimmunized each season. We hypothesized that individuals receivinginfluenza vaccine within the first six months following transplantationwould have similar antibody responses and rates of acute rejection tothose who had been transplanted up to 24 months ago. METHODS: As part of a five-year study of influenza antibodyresponse in lung transplant patients, we obtained serum prior to and 2-4 weeks following influenza immunization for each season. Therecently transplanted group consisted of individuals who wereimmunized within six months of transplant date. The control groupconsisted of individuals who were immunized 6-24 months followingtransplantation. Influenza vaccine antibody concentrations in serumwere measured using hemagglutination inhibition assays.Seroprotection (antibody titer at least 1:40) and seroconversion (four-fold increase in antibody concentration following immunization) ratesbetween the two groups were compared. Rates of acute rejection inmonths following vaccination for the recently transplanted(November, December, and January) were compared to rates inmonths distant from vaccination for the control group (June, July, andAugust). RESULTS: Seroprotection rates were similar between the two groups(Recently transplanted (n=15) vs. control (n=17) 87–93% vs. 88–94%;not significant (NS); c2). Seroconversion rates ranged from 7–33% inrecently transplanted and 25–31% in controls (NS; Fisher’s exact).Episodes of acute rejection rates were similar between the two groups(4 (27%) recently transplanted group vs. 3 (18%) control group; NS;Fisher’s exact). CONCLUSION: The rates of seroprotection, seroconversion, andacute rejection in the recently transplanted and control group aresimilar. Lung transplant patients should receive the influenza vaccineeach season without regard to time since transplantation.

Women’s Health

471. The pharmacokinetics of metoprolol during pregnancy. TracyYep, B.S.1, Sara Eyal, Ph.D.2, Thomas R. Easterling, M.D.3, Danny D.Shen, Ph.D.4, Edward J. Kelly, Ph.D.4, Gary D.V. Hankins, M.D.5,Steve Caritis, M.D.6, Linda Risler, B.S.1, Mary F. Hebert, Pharm.D.,FCCP3; (1)University of Washington Department of Pharmacy,Seattle, WA; (2)Institute of Drug Research, Jerusalem, Israel;(3)University of Washington Departments of Pharmacy and Obstetrics& Gynecology, Seattle, WA; (4)University of Washington, Departmentof Pharmacy, Seattle, WA; (5)University of Texas Medical BranchDepartment of OB/GYN, Galveston, TX; (6)Magee-Womens Hospital,Pittsburgh, PA PURPOSE: The objective of this study was to evaluate the steady-state pharmacokinetics of metoprolol during pregnancy. METHODS: Plasma and urine concentrations of metoprolol and itsmetabolite, α-hydroxymetoprolol, were measured in twelve womentreated with metoprolol (25–750 mg/day) for therapeutic reasons.Maternal and umbilical cord blood samples were obtained at deliveryfrom 4 mothers and breast milk samples were obtained over onedosing interval in 2 mothers. Pharmacokinetic parameters wereassessed by non-compartmental methods. RESULTS: Metoprolol apparent oral clearance is higher duringpregnancy (549±576 L/hr (NS; n=6) mid-pregnancy and 978±702 L/hr(P<0.05; n=9) late pregnancy) than in the non-pregnant state(249±132 L/hr (n=6) postpartum). Correspondingly, α-hydroxymetoprolol formation clearance was higher during pregnancy(82.7±122.8 L/hr (NS, n=5) mid-pregnancy and 106.0±75.4 L/hr(P<0.05, n=8) late pregnancy) than in the non-pregnant state (13.6±9.0L/hr (n=6) postpartum). Metoprolol umbilical cord plasma

concentrations ranged between non-detectable and 3.3 ng/mL.Relative infant exposure through breast milk to metoprolol and a-hydroxymetoprolol combined, was less than 2% of the mother’sweight-adjusted dose. CONCLUSION: Metoprolol pharmacokinetics change duringpregnancy and the magnitude of change is highly variable. Metoprololis readily transferred across the placenta, but exposure to metoprololthrough breast milk is low. Due to the large gestational changes inmetoprolol pharmacokinetics, clinicians should consider using analternative b-blocker in this patient population.

472. Computer algorithm: a more sensitive tool than standardvisual scoring for analyzing immunohistochemistry staining of theplacental vasculature. Michael P. Drozdowicz, Pharm.D., Candidate,20121, Katie Jaenecke, Pharm.D.1, Andrew Tong, Pharm.D.1, AlbertFranco, M.D.2, Daniel Brazeau, Ph.D.3, Nilsa Ramirez, M.D.4, ThomasJ. Barr, B.S., MBA4, William Beyer, BSEE, MSEE4, Patty Fan-Havard, Pharm.D.1; (1)University at Buffalo School of Pharmacy andPharmaceutical Sciences, Amherst, NY; (2)Carolinas Medical Center,Charlotte, NC; (3)University of New England, Portland, ME; (4)TheResearch Institute at Nationwide Children’s Hospital, Columbus, OH PURPOSE: The gold standard for interpreting immunohistochemistry(IHC) stains relies on the subjective visual score made by anexperienced pathologist. Computer analysis of IHC staining may offergreater sensitivity and reliability in detecting changes in proteinexpression. The aim of this study is to assess and compare these twotechniques in their ability to detect differences in protein expression ofb-catenin and VE-cadherin within the placental vasculature. METHODS: Tissue-micro-arrays were created from cores ofplacental samples from healthy mothers (control), gestational diabeticmothers (GDM), and mothers being treated for HIV (n=68) and thenIHC stained for beta-catenin or VE-cadherin. Fetal capillaries wereselected and analyzed for protein staining by a pathologist’s visualinspection and Aperio ImageScope positive pixel count algorithm,which respectively yielded a visual score and pixel count that werebased on the following scale: 1–negative; 2–weakly positive;3–positive; and, 4–strongly positive. RESULTS: Using ANOVA analysis, significant correlations werefound between visual score and strong positive pixel count (p<0.05) aswell as intensity (p<0.05) for b-catenin and VE-cadherin. Computer-aided analysis detected significant differences in staining betweenGDM and control groups for both beta-catenin and VE-cadherin andbetween HIV and control groups for beta-catenin; visual scores failedto detect these differences. CONCLUSION: Our preliminary data suggest that while visualscores and Aperio analysis are correlative, the computer-aidedquantitative method may be more sensitive in the detection ofdifferences between exposure groups than visual examination by aclinical pathologist.

LATE BREAKERS


473. Clindamycin induced acute kidney injury: Is this for real? Nidhi Bansal, MBBS, Jiwan Thapa, MBBS; SUNY Upstate MedicalUniversity, Syracuse, NY PURPOSE: Clindamycin is commonly associated withgastrointestinal side effects. There is paucity of literature on itspotential renal adverse effects. METHODS: We report a case of 70 yo man presenting with legcellulitis. Past medical history was significant for DM2, nephropathy,MRSA infection and left foot ulcers. He recently took oralciprofloxacin without much response. He was allergic to penicillin andcephalosporins. Thus he was empirically started on clindamycinpending cultures. On day 3, serum creatinine rose to 1.7 mg/dl frombaseline of 1.2 mg/dl. There was low grade fever, myalgias, fatiguebut no rash/ joint pains and no signs/symptoms ofhypovolemia/dehydration. Medications were reconciled to discontinueany offending drugs. By day 5, creatinine rose to 2.2 mg/dl. Urineanalysis showed hematuria and pyuria. Differential WBC countrevealed eosinophilia. Other urine, blood and radiologic investigationscouldn’t pinpoint underlying etiology. Repeat medicationreconciliation revealed that clindamycin was the only new drug added.

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We stopped clindamycin considering the possibility of clindamycininduced interstitial nephritis. AKI and symptoms resolved quiteimpressively over few days. Thus a diagnosis of clindamycin inducedacute interstitial nephritis was made. He received IV vancomycinsubsequently, tolerated it well and was discharged to home. RESULTS: Clindamycin is commonly linked to C. difficle colitis andhematologic side effects. It could precipitate tubulointerstitial nephritisand AKI very rarely. Only 11 cases have been reported to FDAdescribing this entity. These account for 0.16% of total side effects.All cases were reported within 1 month of drug administration. Upto50 % have been reported in > 60 years age group. Our patient`sclinical profile matched with these observations. The insult has beenhypothesized to be immune complex mediated however the exactmechanism remains unknown.CONCLUSION: Healthcare professionals should be aware of thisrare, serious but potentially reversible side effect of clindamycin.

474. Adverse drug reactions in ambulatory care with an electronicmedical record and electronic prescribing: Identification andcharacterization. Katy E. Trinkley, Pharm.D., Harrison G. Weed,M.D., M.S., FACP, Stuart J. Beatty, Pharm.D., BCPS, Milap C.Nahata, Pharm.D., M.S., FCCP; Ohio State University Colleges ofPharmacy and Medicine, Columbus, OH PURPOSE: This study was designed to characterize the types andfrequency of adverse drug reactions (ADRs) that occured in a primarycare setting using an electronic medical record (EMR) with electronicprescribing in order to identify features of prescribing which mightavoid ADRs. METHODS: Patients with a new prescription, defined as a newmedication, a dose change, or a discontinuation who were seen at anoutpatient Internal Medicine Clinic were evaluated for ADRs by EMRreview and by telephone interview at 2 and 4 weeks after the newprescription. ADRs were independently assessed for causality,severity, preventability and ameliorability by a physician and apharmacist using a grading instrument. RESULTS: Of the 414 patients enrolled, 63 and 64% completed the1st and 2nd telephone interviews, respectively. From the 835 newprescriptions, 29% were discontinued. Only 65% of thediscontinuations were at the direction of a prescriber and 5% were dueto an ADR. The 85 suspected ADRs were reviewed for causality and42 were determined to be true ADRs. Of these, 21% were preventable,36% ameliorable. There were 6 serious and 1 fatal or life-threateningADRs. Preventable or ameliorable ADRs may have been avoided bybetter communication or prescribing practices. CONCLUSION: ADRs continue to occur among outpatients despiteuse of an EMR with electronic prescribing. A substantial portion ofthese ADRs could be prevented with better communication andprescribing practices.

Ambulatory Care

475. Effectivenss of a pharmacist managed hypertension sharedmedical appointment. Rachel N. Chandra, Pharm.D.; DaytonVeterans Affairs Medical Center, Dayton, OH PURPOSE: Shared medical appointments (SMA) are an alternativemodel for healthcare delivery in chronic diseases. In 2006 a SMA wasinitiated and led by a clinical pharmacist at the Dayton VAMC in aneffort to optimize outcomes in high risk poorly controlledhypertensive veterans. Multiple models for SMAs have beendeveloped. The model employed at the Dayton VAMC was ahybridized form as described by Noffsinger. This SMA model allowedfor a multidisciplinary approach, improved access with reproduciblemethods. METHODS: Patients were referred to the SMA by their primary careteams (PCT). The SMA entailed an estimated 90 minute session whichmet weekly. Interventions were based on current prescribingguidelines and recommendations from JNC-7. Nutrition and nursingservices routinely participated. Patients were discharged when goalblood pressure was achieved. Groups were patients who received carefrom the SMA versus patients referred but declined to participate inthe SMA and instead received usual care by their PCT. The variablesinclude systolic blood pressure (SBP), admissions, clinic visits,medication classes and co morbidities. A total of 628 patients were

referred, 72% (450) were seen in the SMA and 18% (178) werefollowed by their primary care teams. RESULTS: The mean SMA clinic visits were 3.5. The two groups didnot differ statistically with regards to age, sex, BMI, co-morbidities,and serum creatinine. Mean admissions for the two groups were 2.7(SMA group) vs. 3.5 (comparator group). The initial mean SBP were149.6 and 149.5 mm Hg respectively. SBP in both groups decreasedhowever the change was larger in the SMA vs. comparator (-11.3 vs. -5.7 mmHg) (p<0.05). CONCLUSION: Pharmacists led multidisciplinary SMA is aneffective model in the management of hypertension among patientswith multiple co morbidities.

Cardiovascular

476E. Is anemia associated with heart failure? NHANES database(2005–2006) analysis. Abdulkhaliq J. Alsalman, M.S., Yousef N.Alhashem, M.S., Ali M. Alhammad, M.S., Maitham A. Al Hawaj,B.S., Mohammed A. Al Mohaini, B.S., Spencer E. Harpe, Pharm.D.,Ph.D., M.P.H., Benjamin W. Van Tassell, Pharm.D., BCPS; VirginiaCommonwealth University, Richmond, VA PURPOSE: Anemia is a prevalent public health problem associatedwith increased risk of morbidity and mortality. It is also associatedwith cardiovascular disorders (CVDs) including heart failure (HF). Ina large community study, 58% of HF patients had anemia. There is awide variation in the reported prevalence of anemia among HFpatients (7–50%). This community based study investigated whetheranemia is associated with HF using data from National Health andNutrition Examination Survey (NHANES) which is a national surveyto assess the health and nutritional status in the United States. METHODS: NHANES data from the 2005–2006 administration werecombined and analyzed cross-sectionally. Descriptive statistics andunivariate comparisons were used as appropriate. Weightedmultivariable logistic regression was used to predict and compute oddsratios (OR) and 95% confidence intervals (CI) of the associationbetween HF and anemia prevalence. RESULTS: There were 953 respondents with anemia, and 180respondents had HF. Among those with anemia, the proportion ofAfrican Americans was significantly higher than Caucasians (46% vs.31%; p<0.001; respectively). Respondents with anemia weresignificantly more likely to have cancer, other CVDs status, and bepregnant than those without anemia (p<0.001, p<0.001, and p<0.002,respectively). In addition, prevalence of anemia was significantlyhigher in respondents with HF as compared to those with other CVDs(18% vs. 4%; p<0.001). Approximately 10% of HF respondents hadanemia compared to just 2% among those without HF (OR=5.09,CI=5.08–5.11). This association remained statistically significant afteradjusting for age, race, pregnancy status, cancer, smoking status, andother CVDs (OR=5.8, CI=5.54–5.96). CONCLUSION: According to this study, the prevalence of anemiaamong HF patients is relatively high. African Americans and thosewith HF are more likely to experience anemia. The associationbetween HF and anemia remained after controlling for confounders. Published in Published in Health Value, 2011;14(3):PCV26.

477. Blockade of sodium entry ameliorates arrhythmias duringcalcium overload. Przemyslaw Radwanski, Pharm.D., Ph.D., StevenPoelzing, Ph.D.; University of Utah, Salt Lake City, UT PURPOSE: Heart failure and Andersen-Tawil syndrome Type 1(ATS1), both linked to inward-rectifier potassium current (IK1)abnormalities, are associated with ventricular arrhythmias. Wepreviously demonstrated that a guinea pig model of drug-inducedATS1 (DI-ATS1) evidenced increased arrhythmia incidencepreferentially originating from regions with increased Na+/Ca2+-exchanger (NCX) expression, suggesting a role not only for Ca2+ butalso for Na+ in ATS1-associated arrhythmogenesis. Therefore, wehypothesized that Na+ channel blockade during DI-ATS1 will not onlymitigate perturbations in Ca2+ handling but also will amelioratearrhythmia burden. METHODS: DI-ATS1 was induced by partial IK1 blockade with 10μM BaCl2 and 2mM [K+]o. Optical mapping with di-4-ANEPPS andindo-1 dyes were used to quantify ventricular conduction velocity(CV) and record Ca2+ transients respectively from Langendorff


perfused guinea pig ventricles. RESULTS: Previously, the cardiac and not the tetrodotoxin (TTX)-sensitive Na+ channels have been demonstrated to have a critical rolein CV. Hence, as expected Na+ channel blockade with 100 nM TTXduring DI-ATS1 did not alter CV (n=6; p=ns). On the other hand,blockade with 1µM flecainide and 30 µM ranolazine during DI-ATS1decreased CV by 14±5% (p<0.05). Furthermore, all modalities of Na+

channel blockade decreased Ca2+ transient amplitude by 15±4%(p<0.05). Importantly, Na+ channel blockade during DI-ATS1 eitherthrough TTX-sensitive or cardiac Na+ channels (flecainide andranolazine) ameliorated the arrhythmia burden relative to DI-ATS1alone. CONCLUSION: These data suggest that cytosolic Na+ entry isnecessary for arrhythmogenesis. Further, this is first report onranolazine’s effect on ventricular excitation suggesting similarpharmacology to flecainide. Na+ influx might be necessary forpropagation of changes in membrane potential secondary tospontaneous Ca2+ release. Alternatively, Na+ influx can itself serve as atrigger for Ca2+ release. Importantly, inhibiting cytosolic Na+ influxmay offer a potential therapeutic target to alleviate arrhythmia burdenduring states of Ca2+ overload secondary to loss of IK1 function.


478. A community pharmacy, diabetes management program toimprove biometric and cardiac risk factors. Jamie Vortherms,Pharm.D., Michael Taitel, Ph.D., Leonard Fensterheim, M.P.H.,Heather Kirkham, Ph.D., Ian Duncan, FSA; Walgreens, Deerfield, IL PURPOSE: As a trusted source of healthcare information andservices, pharmacists are ideally positioned to engage patients on thecomprehensive topic of diabetes management. This study evaluatedclinical changes in patients with diabetes who were enrolled in apharmacy-led intervention program. METHODS: The study period for this longitudinal cohort, pre-postresearch was January 1, 2010 (program inception) until April 30, 2011.Community pharmacists, who were certified in diabetes self-management, provided face-to-face, individual diabetes counseling topersons with type 2 diabetes and collected seven clinical biomarkersvia portable, point-of-care testing devices: glycosylated hemoglobin(A1c), total cholesterol (TC), low-density lipoprotein cholesterol(LDL), high-density lipoprotein cholesterol (HDL), triglycerides(TRIG), diastolic blood pressure (DBP), and systolic blood pressure(SBP). The Framingham risk score was used to estimate overallreduction in risk for cardiac complications RESULTS: As of April 2011, 189 participants had data available fromtheir 90-day evaluation. The average age of participants was 54 years(SD ± 9.3), and 53% (n = 100) were female. Comparing baseline tofirst follow-up, five of seven biomarkers—A1C, TC, HDL, TRIG, andSBP—significantly improved (p<0.05). On average, participants in theprogram decreased their 10-year Framingham risk score by almost10% (p<0.01). CONCLUSIONS: These early program results are consistent withother pharmacist-led intervention studies and suggest that pharmacistscan play a crucial role in education and management of the diabetespatient. While not all metrics demonstrated significant improvement,the collective effect was statistically significant and more importantlymay be clinically significant.

Education/Training

479E. The effect of integration of pharmaceutical care componentsin pharmacy schools curricula on medication adherence in Syria.Anas Bahnassi, Ph.D.; Arab International University, Damascus, Syria PURPOSE: Understand the impact of inclusion of a modified clinicalpharmacy course with a strong pharmaceutical care content onstudents of a Syrian university particularly to promote medicationadherence among patients and its associated effects on blood pressure(BP) and low density lipoprotein cholesterol (LDL-C). METHODS: Modifications were applied to clinical pharmacycurriculum. The passing students were asked to conduct a three phasal,prespective study, 200 community based patients aged 60 years orolder taking at least 4 different maintainance medications weremonitored over 12 months. Phases included; a 2-month baseline-

adherence phase, a 6-month intervention phase where standardizedmedication education and direct pharmaceutical care have beenclosely carried out by students followed by a 4-month randomizedobservational phase where patients were randomly divided intocontinued pharmaceutical care group and usual care group. Theprimary endpoint was to measure medication adherence in theobservational phase vs baseline-adherence phase, secondary endpointsincluded the measurement of the changes in BP and LDL-C values. RESULTS: Among enrolled patients, CVD risk factors included 186patients with treated hypertention and 106 patients with treateddyslipidemia. Baseline medication adherence was 41% ±[11.3], Thepercentage increased by the end of intervention phase to 86.7%±[9.2](p<0.001). Four months after randomizations, patients with usual careshowed a decrease in the persistance of medication adherence to71.3%±[8.4] where as the pharmaceutical care group showed a rate ofmedication adherence of 85.2%±[9.4] (p<0.001) and a significantdecrease in systolic BP in pharmaceutical care group vs usual caregroup. The changes were insignificant over the same period of timefor LDL-C levels. CONCLUSION: Pharmaceutical care inclusion in the pharmacycurriculum in Syrian universities is still limited. Pharmaceutical carepractice in community pharmacies depends heavily on individualinitiatives. The application of a pharmaceutical care program hasachieved an increase in medication adherence, persistance, andsignificant reductions in clinical parameters.Interuption/discontinuation of this program is associated withdecreased levels of medication adherence and direct effect on clinicalparameters. Presented at Presented at the Conference of the Arab PharmacistsAssociation in Damascus, Syria.

480. Evaluation of pharmacy resident perceptions, knowledge andinterventions following a trauma response training program.Stephen Rolfe, Pharm.D., BCPS1, Kimberly A. Pesaturo, Pharm.D.,BCPS2, Jeffrey Dandurand, Pharm.D., BCPS3; (1)University of NewEngland, College of Pharmacy, Portland, ME; (2)MassachusettsCollege of Pharmacy and Health Sciences - Worcester/Manchester,Worcester, MA; (3)Clinical Pharmacy Associates, Laurel, MD PURPOSE: The purpose of this study was to evaluate pharmacyresident perceptions of trauma response, perceived baseline level oftrauma-related pharmacy knowledge and categorized clinicalinterventions over a six month period following educational andpractical training. METHODS: A pharmacy-focused trauma response training programwas initiated for the PGY-1 and PGY-2 pharmacy residents in theemergency department (ED) at a large urban level-1 academic medicalcenter. Residents completed didactic training during their initialresidency orientation followed by preceptor-supported practicaltraining. At the initiation of the training, pharmacy residents wereasked to complete a survey that detailed the resident’s perceived levelof experience, comfort, and knowledge base for trauma response in anED. Six months later, residents received a second survey as a follow-up measure of resident experience, comfort and knowledge. Theprimary and secondary outcomes of this study were the change inperception between the first and second survey and thecharacterization of pharmacy-related trauma interventions over theentire study period, respectively. RESULTS: Eleven PGY-1 and PGY-2 pharmacy residentsparticipated in the didactic training and subsequent trauma responseprogram. A Mann-Whitney U test showed that baseline median scoresrelated to resident comfort and perceived knowledge base significantlyimproved for twelve of fifteen questions at the six-month follow-upsurvey. Residents recorded participation in 399 traumas over sixmonths. At least one intervention was made during 43% of traumasout of the 239 patients that received medications. The top three typesof resident interventions were initiation of therapy, dosagerecommendation, and drug information. CONCLUSION: Completion of a trauma training program andsubsequent preceptor-supported trauma experience allowed pharmacyresidents increased comfort and perceived knowledge base withtrauma response. Pharmacy residents were effective at intervening intraumas.

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481. Pursuit of post-graduate training programs upon graduation. Olga Hilas, Pharm.D., BCPS, CGP, Sharon See, Pharm.D., BCPS; St.John’s University College of Pharmacy and Allied Health Professions,Queens, NY PURPOSE: The purpose of this study was to assess student interest inpost-graduate training programs upon graduation and the attainment ofpost-graduate training positions. METHODS: This study was designed to anonymously collectinformation from sixth-year pharmacy students (n = 238) regardingtheir pursuit and attainment of post-graduate residency or fellowshipprograms using Survey Monkey. Student participation was completelyvoluntary and all study materials were approved by the university’sInstitutional Review Board. The survey was emailed to students andweekly reminders were sent over a 4-week period. Survey questionsincluded inquiries regarding pursuit of post-graduate trainingpositions, cities and states of programs applied to, interviews obtained,“match” vs. “non-match” applications, academic history,extracurricular activities, professional affiliations, attainment of post-graduate positions and other plans upon graduation. RESULTS: Fifty-eight percent of students completed the survey. Ofthese students, 25% sought a post-graduate pharmacy practiceresidency position. Of the remaining 75%, 4% sought a post-graduatefellowship program. The majority of students reported seekingpositions in states along the eastern coast of the country, with only 3%applying to states in the west and midwest. Almost 50% of all studentsmaintained cumulative grade point averages of 3.0 to 3.4, followed by32% with averages of 3.5 to 4.0. The majority also participated in avariety of extracurricular activities, community service projects andprofessional organizations, while a minority participated in scholarlyactivities. Seventy-nine percent of student obtained interviews, butonly 14 students reported obtaining positions. One student obtained anon-accredited residency position and no students obtained fellowshippositions. CONCLUSION: The results obtained from this study provide facultymembers with valuable insight into student perceptions of andapproach to pursuing post-graduate training programs. Thisinformation will be utilized to develop more effective educationalsessions on post-graduate pharmacy training and opportunities forgrowth within the profession.

482. Assessment of the prevalence, structure and function of“informal” student chapters of ACCP. Andrew Smith, Pharm.D.;UMKC School of Pharmacy, Kansas City, MO PURPOSE: A number of “informal” chapters of ACCP have begun toform to allow students increased opportunities to work towards themission of ACCP on their campus. However, there is no clearunderstanding of the prevalence of these “informal” chapters as wellas how they are structured and what functions they perform. Thereforethis survey study was performed to describe the current state of‘informal’ ACCP chapters at schools or colleges of pharmacy. METHODS: A survey was designed that asked information such assize and type of institution, demographic information about thecollege of pharmacy liaison, utilization of ACCP student resources, thepresence of and the structure and function of an ‘informal’ chapter ofACCP. The survey is being electronically sent to College of PharmacyLiaisons registered with ACCP. The response period will be onemonth, with one reminder email after two weeks. The primaryoutcome of this study is a descriptive analysis of ‘informal’ studentchapters of ACCP, to aid college of pharmacy liaisons that may beplanning to start a chapter. Descriptive data will be presented usingmean and standard deviation. Comparison between data will be madeusing student’s t-test for continuous variables and c2 test for nominalor ordinal items. A p-value of < 0.05 will be considered staticallysignificant. Statistical analysis will be performed using SPSS version18 (SPSS, Inc., Chicago, IL). RESULTS: Data collection will begin shortly and will be completed inAugust of 2011. Information presented will include demographic data,prevalence, structure and function of ‘informal’ chapters of ACCP. Datawill be examined for predictors of the successful formation of an‘informal’ student chapter.

Emergency Medicine

483. Development of a pharmacy computerized inventoryprogram (PCIP) in an emergency department/intensive care unit,outpatient care, and a pediatric hospital in Haiti. Michelle Holm,Pharm.D., R.Ph.1, John Rueter, R.Ph.1, Maria Rudis, Pharm.D., R.Ph.1,Chris Arendt, Pharm.D., RPh1, Nikki Jensen,2; (1)Mayo Clinic,Rochester, MN; (2)PlanetJ Corporation, Escondido, CA PURPOSE: After the 2010 earthquake in Haiti, a 220 bedcomprehensive health facility developed rapidly in Port-au-Prince tocare for maladies ranging from trauma to cholera. Our institution’smission at this facility was to help develop sustainable systems.Specifically, our objective was to develop a Pharmacy ComputerizedInventory Program (PCIP) to monitor medication utilization and allowstaff to provide sustainable patient care in 3 different hospital settings. METHODS: A needs assessment of PCIP requirements wasperformed by our pharmacists with the facility’s medical director.Needs included real-time data assessment of medication usage in 3hospitals (ED/ICU, Inpatient / Ambulatory Care, and Pediatrics);simplicity and sustainability by local hospital personnel; andaccommodation to further service expansion. Commercially availableproducts did not meet identified needs. We partnered with a companytailoring web application tools and developed a PCIP thataccomplished all identified needs. A plan for implementation of thePCIP included on-site and remote education of end-users. RESULTS: A web-based PCIP was programmed in Haitian Creoleand English. It encompasses all phases of the medication use processincluding: drug ordering, hospital drug requests, filling the drugrequests, distribution and dispensing of the medications at the 3hospitals; inventory of medications on hand and graphic charting ofmedication usage. The Haitian pharmacy and nursing staff weretrained by 3 pharmacists from our institution (and local interpreters).Implementation including education occurred within weeks ofprogram development and prior to completion of the medical mission. CONCLUSION: The 3 Haitian hospitals now have the means toidentify and order medications with a critically low supply as well astrack usage for future medication needs. PCIP allows hospital staff toprovide sustainable medication delivery and patient care with asimple, easy to use web based program customized to local needs.

Geriatrics

484. Clinical interventions of pharmacy practice residents on anacute care for elders unit. Olga Hilas, Pharm.D., M.P.H., BCPS,CGP; St. John’s University College of Pharmacy and Allied HealthProfessions, Queens, NY PURPOSE: The purpose of this study was to evaluate the clinicalinterventions proposed by post-graduate pharmacy practice residentsduring a 4-week experiential rotation on an inpatient geriatric unit. METHODS: This study was designed to evaluate the types of clinicalinterventions made by pharmacy practice residents, time allotted formaking and following-up on necessary recommendations and potentialcost-savings associated with the interventions. Three residentsdocumented all interventions proposed to the clinicalpharmacist/preceptor and recommended to the medical team over aperiod of 4 weeks. Data obtained included the category of theintervention, drug(s) involved, estimated time of intervention, status ofrecommendation and estimated cost-savings of the intervention. Alldata was transferred and evaluated using the MedKeeper (RxRoundsInterventions) program. The hospital Institutional Review Boardreviewed and approved this study. RESULTS: A total of 91 interventions were identified and proposedby the pharmacy practice residents during the 4-week period. Morethan 90% of the interventions were accepted by the medical residentsand attending physicians (after consulting with the clinicalpharmacist/preceptor). Approximately half of all interventionsinvolved inappropriate drug dosing or utilization, mainly in patientswith renal impairment. Other types of interventions includedrecommendations for appropriate drug monitoring, therapeuticnecessity of certain medications, changes to standing and as neededorders, inappropriate or unnecessary therapy, and clinically significantinteractions. Average time needed for an intervention and averagesavings per intervention varied according to category, but overall were


approximately 15 minutes and $100, respectively. CONCLUSION: The results obtained from this study demonstratethe importance of thorough medication evaluations on a geriatric unitand the impact clinical pharmacists have on optimizing patient care.Training post-graduate pharmacy residents to identify potentialtherapeutic issues, formulate appropriate recommendations andfollow-up on the status of those recommendations is imperative totheir development into successful practitioners.

Medication Safety

485. Evaluation of infusion-related reactions with iron sucrose at alarge tertiary medical center. Diana R. Mack, Pharm.D.1, LeighAnne Hylton Gravatt, Pharm.D., BCPS2, Spencer E. Harpe, Pharm.D.,Ph.D., M.P.H.2; (1)Virginia Commonwealth University Health System,Richmond, VA; (2)Virginia Commonwealth University School ofPharmacy, Richmond, VA PURPOSE: This study was conducted to determine the associationbetween intravenous iron sucrose dose and infusion rate with thedevelopment of an infusion-related reaction. Of the currently availableintravenous iron preparations, iron sucrose has been associated with amore favorable safety profile thus has become the agent of choice atmany institutions. Clinicians at Virginia Commonwealth UniversityHealth System (VCUHS) are prescribing high-dose iron sucroseinfusions (> 300 mg) which is supported by limited data and adversedrug events associated with iron sucrose have been recorded throughthe institution’s Patient Safety Net system. METHODS: This retrospective case-control evaluation wasconducted from September 12, 2005 through August 31, 2010. Casepatients identified via adverse event reports were included if they were≥ 18 years of age and received iron sucrose with a subsequentinfusion-related reaction. Patients who received iron sucrose and didnot experience an infusion-related reaction were identified as controlsand matched at a 2:1 ratio to case patients. RESULTS: A total of 9 case and 18 control patients were eligible forinclusion. Approximately 78% of all patients were female with a mean± SD age of 36 ± 10.4 years. Thirty percent of all patients werereceiving intravenous iron sucrose for anemia of chronic kidneydisease. The most common signs and symptoms of an infusion-relatedreaction included hypotension, paresthesias, rash, and extremityswelling. In the bivariate analysis of dose compared to development ofan infusion-related reaction, case patients were significantly morelikely to have received a dose ≥ 400 mg of iron sucrose (OR [95% CI]= 9.16 [1.07–78.31]; p=0.043). Statistical significance was not foundwith regards to infusion rate. CONCLUSION: Our findings suggest that high dose intravenous ironsucrose (≥ 400 mg) may be associated with a higher incidence ofinfusion-related reactions.

Psychiatry

486E. Effects of pharmacist drug regimen reviews on physicians’compliance with recommended laboratory monitoring criteria forpsychotropic medications at a state supported living center.Abimbola Farinde, Pharm.D., M.S., BCPP, CGP, FASCP, FACA;Lufkin State Supported Living Center, Pollok, TX PURPOSE: Many individuals that reside in state supported livingcenters for the developmental disabled and/or mentally impaired canbe placed on a myriad of psychotropic medications to treat theirdisturbances. Appropriate and timely laboratory tests must beperformed on all psychotropic medications to determine therapeuticlevels for effectiveness and identify toxicities. It has been shown thatfailure to monitor drug therapy is among one of the most frequentcauses of preventable adverse drug events. The errors that areassociated with laboratory monitoring to generally tend to occur whenthere is a lack of baseline or follow-up laboratory work, or a delay inactions being taken to address abnormal lab results. The objective ofthis study is to determine if a pharmacist performing quarterly drugregimen reviews at a state supported living center can improve thecompliance rate as it relates to meeting laboratory monitoringparameters for psychotropic medications. METHODS: All the necessary documents/forms were submitted tothe Texas Department of State Health Services Mental Health and

Mental Retardation Research Administration Institutional ReviewBoard #2 in Austin, Texas for review and approval. A retrospectivechart review was performed on 50 residents at the Lufkin StateSupported Living Center with an Axis I diagnosis of a psychoticdisorder, bipolar disorder, or autism and Axis II diagnosis of mentalretardation. RESULTS: The performance of a quarterly drug regimen review by apharmacist increased the likelihood of appropriate labs being done forindividuals on psychotropic medications. From the fifty charts thatwere reviewed, residents who received the pharmacists’ reviews(75%) had the recommended labs performed. CONCLUSION: The results of this chart review will determine if apharmacist’s recommendations for appropriate laboratory monitoringof psychotropic medications can be instrumental in assessing foreffectiveness of psychotropic medication therapy and minimize thedevelopment of adverse drug events or potential toxicities. Presented at College of Neurologic and Psychiatric Pharmacy,Phoenix, Arizona, May 1-4, 2011 Texas Society of Health SystemPharmacists San Antonio, Texas, April 14-17, 2011


487E. Impact of conversion to sirolimus-based immuno-suppression on fibrosis progression in HCV+ liver transplantrecipients. Christin Rogers, Pharm.D.1, Daniel R. Stevens, B.S.2,Michael Curry, M.D.1; (1)Beth Israel Deaconess Medical Center,Boston, MA; (2)Northeastern University, Boston, MA PURPOSE: Hepatitis C (HCV) is the leading indication for livertransplantation. The optimal immunosuppression regimen for HCV+liver transplant recipients remains unknown. The purpose of our studywas to evaluate the impact of conversion from a calcineurin inhibitor(CNI) to sirolimus on fibrosis progression in HCV+ liver transplant(LT) recipients. METHODS: Between May 2002 and August 2010, 115 HCV+ LT’swere performed. Fifty-five patients were converted from CNI to SRL,of which 37 received SRL for ≥ 6 weeks with ≥ 100 days between firstand last biopsy. Of the 60 maintained on CNI, 42 met criteria forinclusion as controls. Protocol liver biopsies assessed using theMetavir score were performed at 6 months, 12 months, annually andas clinically indicated. RESULTS: Baseline donor and recipient demographics did not differbetween the groups. Patients converted to SRL demonstrated asignificantly lower median annual fibrosis progression rate than thoseremaining on CNI (initial to final biopsy 0.38 vs. 0.85, p=0.006).Fifty-one percent of patients discontinued sirolimus therapy. Durationof sirolimus use appeared to impact fibrosis progression rates (>2 yr(0.20) vs. 6 mos–2 yr (0.46) vs. < 6 mos (0.91), p=0.42). KaplanMeier analysis demonstrated that a significantly lower proportion ofpatients converted to SRL progressed to ≥ stage 2 fibrosis at 1 (92%vs. 71%, p=0.02), 3 (74% vs. 46%, p=0.009), 5 (57% vs. 32%,p=0.01), and 7 (46% vs. 19%, p=0.008) years post transplant. Amultivariate analysis identified continuation of CNI therapy as apotential predictor of “rapid fibrosis” (stage 2 or greater fibrosis at 1year post transplant), with patients remaining on CNI being 2.8 timesmore likely to develop rapid fibrosis (p=0.07). CONCLUSION: Conversion from CNI to SRL-based IS in HCV+ LTrecipients may slow fibrosis progression post transplant. Large scalemulticenter studies are needed to confirm this finding. Presented at American Transplant Congress, Philadelphia, PA, April30–May 4, 2011

PRN History Paper

488. Drug Information Practice and Research Network history:2002–2009Kristina E. Ward, B.S., Pharm.D., BCPS 1, Beatriz Manzor Mitrzyk,Pharm.D., BCPS 2, Philip J. Gregory, Pharm.D. 3, Andrea L.McKeever, Pharm.D., BCPS4; (1) University of Rhode Island,Kingston, RI; (2) Mitrzyk Medical Communications, LLC, Northville,MI; (3) Center for Drug Information and Evidence Based Practice(CDIEBP), Creighton University School of Pharmacy and HealthProfessions, Omaha, NE; (4) South University School of Pharmacy,Savannah, GA

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PURPOSE: To commemorate the thirtieth anniversary of theAmerican College of Clinical Pharmacy (ACCP), all Practice andResearch Networks (PRN) in ACCP were encouraged to documenttheir history. METHODS: A volunteer working group from the DI PRN gatheredinformation from previous PRN officers, business meeting minutes,financial records, newsletters, and emails to develop a formaldocument recording the history of the DI PRN through 2009. RESULTS: The DI PRN is relatively new, recognized in late 2002. Asof 2009, DI PRN has over 200 members and represents practitionersfrom academia, clinical practice, health-systems, pharmaceuticalindustry, managed care organizations, medical information publishers,and medical education providers in the United States and abroad. TheDI PRN has several goals among which is the opportunity to network,problem-solve, and discuss professional challenges related to druginformation and informatics. The DI PRN provides educationalprogramming for Focus Sessions at ACCP meetings and typicallyoffers an educational program during the DI PRN business meeting atthe Annual Meeting. Since 2007, educational programs at the businessmeetings have been provided through administration of a DI ResidentPresentation Award which aims to provide a venue for an immediate-past resident to present the results of their residency research project.The DI PRN considers supporting the Frontiers Fund a priority. CONCLUSION: The DI PRN represents a diverse group ofpharmacists who develop, write, and provide drug information and weendeavor to represent all of these practitioners. We value the opinionsof our members and continuously update our PRN initiatives based onmember feedback. We support ACCP-directed research and legislativeinitiatives, especially when related to drug information practice andseek out opportunities to collaborate with other PRNs to promoteclinical pharmacy practice.

Infectious Diseases

489. Opportunities to improve fluoroquinolone prescribing: Apilot study. Robert Eastin, Pharm.D., Amie Nguyen, Pharm.D.,Maggie Brownell, Pharm.D., Donna Agan, Ed.D., Harminder Sikand,Pharm.D. Scripps Mercy Hospital San Diego, CA; Scripps MemorialHospital La Jolla, CA.BACKGROUND: Fluoroquinolones (FQ) are frequently prescribedbecause of their broad spectrum of activity, dosing convenience, andfavorable safety profile. Overuse of these agents leads to decreasedbacterial susceptibilities and therefore, decreased efficacy. At ScrippsMercy Hospital San Diego (SM) and Scripps Memorial Hospital LaJolla (SL), FQs are the most common prescribed class of antibioticswith levofloxacin (LVQ) being the highest in the class. Despitedecreased susceptibilities to FQs over the past ten years, most notablyin gram negative organisms, FQ utilization continues to be high. Theobjective of this study is to investigate the efficacy of empiriclevofloxacin, based on microbiology results, at an academic (SM) andcommunity (SL) institution within the system, and to ascertain de-escalation practices.METHODS: A retrospective review was conducted between October2010 and April 2011. Patients were included if they received LVQempirically, had positive cultures, and remained hospitalized untilfinal cultures and sensitivities (C&S) were reported. RESULTS: A total of 2000 patients were screened and 204 patientsmet study criteria; 104 at SM, and 100 at SL. Based on final

microbiological results, empiric FQ therapy could have been avoidedin 46% of patients at SM and 39% of patients at SL (p=0.3). Thepercentage of patients found to have an infection resistant tolevofloxacin was 28% and 17% at SM and SL, respectively (p=0.063).De-escalation occurred in 28% at SM vs. 23% at SL (p=0.42), and de-escalation opportunities were missed in 20% at SM vs. 48% at SL(p=0.00003). CONCLUSION: At SM and SL combined, FQ therapy was notindicated in nearly half of patients. Both hospitals failed to de-escalateto narrower spectrum antimicrobial therapy when the opportunityarose at least 20% of the time. Additionally, de-escalation occurredmore frequently at the academic institution.


490. Prevalence of adverse drug events in three Veterans Affairsnursing homes Zachary A. Marcum, Pharm.D., M.S., Kelly L. Rovesti, Pharm.D.,Michael C. Behrens, Pharm.D., Michael W. Logsdon, Pharm.D., JillMyers, Pharm.D., Susan D. Francis, Pharm.D., Sean M. Jeffery,Pharm.D., Sherrie L. Aspinall, Pharm.D., M.S., Joseph T. Hanlon,Pharm.D., M.S., Steven M. Handler, M.D., Ph.D. University ofPittsburgh, Pittsburgh, PA; Veterans Affairs Pittsburgh HealthcareSystem, Pittsburgh, PA; Durham Veterans Affairs Medical Center,Durham, NC; Veterans Affairs Connecticut Healthcare System, WestHaven, CT; Veterans Affairs Center for Medication Safety, Hines, ILPURPOSE: To describe the one-month point prevalence of andfactors associated with adverse drug events (ADEs) in three VANursing Homes (NHs) detected by a Trigger Tool (allows for rapidmanual chart review using abnormal laboratory values and potentiallyassociated medications).METHODS: This cross-sectional study assessed 321 Veteransresiding in one of three VA NHs (Durham, NC; Pittsburgh, PA; WestHaven, CT) between 10/01/2010 and 10/31/2010. Electronic medicalrecords were screened to identify residents with ≥1 abnormallaboratory value specified in the Trigger Tool. An ADE was defined asthe administration of medication that could cause the abnormallaboratory value. Descriptive statistics and multivariable Poissonregression models were used for statistical analysis.RESULTS: One hundred sixty-two Veterans were included (meanage, 70.6 years; mean # of regularly scheduled medications, 13.3;mean # of chronic medical conditions, 9.7). Ninety-nine ADEsinvolving 146 medications occurred in 20.2% (65/321) of Veterans.The most common ADEs were acute kidney injury (n=30 residents)associated with ACE inhibitors/ARBs and/or loop diuretics,hypokalemia (n=18) related to loop diuretics and/or b-lactamantimicrobials, hypoglycemia (n=13) in Veterans receiving insulinand/or b-blockers, and hyperkalemia (n=10) associated with ACEinhibitors/ARBs and/or beta-blockers. While controlling fordemographic and other health status factors, the total number ofregularly scheduled medications (Incidence Rate Ratio [IRR] 1.04,95% CI 1.01–1.08) and number of chronic conditions (IRR 1.06, 95%CI 1.02–1.11) were associated with an increased risk of ADEs.CONCLUSIONS: ADEs detected using a Trigger Tool are commonin Veterans residing in NHs and are associated with the number ofmedications and chronic medical conditions. Future intervention trialsshould be conducted to assess the impact of ADE detection andmanagement in the nursing home setting using the Trigger Tool.

ACCP 2011 ANNUAL MEETING ABSTRACTS—AUTHOR INDEX

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Acquisto Nicole M: Implementation and evaluation of a recombinantactivated factor VII guideline for uncontrolled bleeding 318

Agalu Asrat: Medication errors and associated factors in the intensivecare unit Jimma University specialized hospital in Ethiopia, April,2011 46

Al-Dahir Sara: Pharmacists and pharmacy students knowledge andattitudes regarding patients with disabilities in Qatar 43

Al-Dahir Sara: Qatar University pharmacy students interest andconcerns related to international professional experience rotations65

Al-Fayoumi Suliman: ADME properties of [14C]-ACU-4429following a single oral dose in healthy volunteers 228

Al-Omar Suha M: Characteristics and clinical course of pediatricpatients admitted with chemotherapy-related febrile neutropenia181

Alessi Thomas: Aliskiren/Valsartan combination is more effective thanvalsartan monotherapy in dipper and non-dipper hypertensivepatients 26E

Alhammad Ali: Drug-induced acute renal failure using the FDAadverse event reporting system database 458

Allen Samantha M: Evaluation of statin therapy in patients over 40years old with diabetes mellitus in a family medicine residencysetting 420

Alsalman Abdulkhaliq J: Is anemia associated with heart failure?NHANES database (2005–2006) analysis 476E

Amelung Kyle A: Benzodiazepine use in alcohol withdrawalsyndrome at an academic medical center 469

Amy Donihi: Avoidance of sulfonylureas in hospitalized patients athigh risk for hypoglycemia: Effectiveness of an email alert 376

Ansara Alexander J: Impact of inappropriate vitamin K use formanagement of elevated international normalized ratios on hospitallength of stay 279

Anthes Ananth: Improving adverse drug event detection in critically illpatients through intensive care unit transfer summary screening 5E

Armahizer Michael J: Comparing drug-drug interaction severity forclinician opinion to proprietary databases 352

Armahizer Michael J: Evaluating the occurrence of QT prolongationresulting from drug-drug interactions 4E

Armstrong Carrie M: Evaluation of smoking rates and nicotinedependence within Sullivan University System 426

Arnold Lindsay M: Increasing the efficacy of heparin infusionsthrough computer-calculated weight-based infusions with auto-populated infusion doses and partial thromboplastin time orders 38

Asoh Ifeoma: Comparison of sodium acetate and sodium chloride onclinical outcomes in patients with intracranial injury 58

Aspinall Sherrie: Impact of pharmacist-managed erythropoiesis-stimulating agents clinics for non-dialysis chronic kidney diseasepatients 174

Assimon Magdalene M: Daily home hemodialysis versus conventionalin-center hemodialysis: evaluation of biomarkers of vascularcalcification and management of mineral and bone disorder 378

Austin Megan E: Evaluation of a potassium replacement protocol innon-ICU patients at an urban safety net hospital 451

Axford Katie L: A retrospective comparison of daptomycin thrice-weekly versus Q48H dosing in hemodialysis patients withvancomycin-resistant enterococcus or methicillin-resistantStaphylococcus aureus bacteremia 131

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Baculik Tanya: CANVAS 1 and 2: Analysis of clinical response at Day3 from 2 phase III trials of ceftaroline fosamil vs vancomycin plusaztreonam in the treatment of complicated skin and skin structureinfections 146E

Badal Robert E: Impact of NXL104 on ceftaroline MICs for bacteriaproducing extended-spectrum, AmpC, or KPC �-lactamases 137E

Bahnassi Anas: The effect of integration of pharmaceutical carecomponents in pharmacy schools curricula on medicationadherence in Syria 479E

Bailey Jennifer L: Evaluation of colistimethate use in the ShockTrauma Center at the University of Maryland Medical Center 162

Baker William L: Does magnesium L-lactate improve quality of life inpatients with an implantable cardioverter defibrillator? 31

Baker William L: Safety of biologic treatments for moderate to severeplaque psoriasis: a systematic review, basic meta-analysis, andBayesian mixed treatment comparison 59

Bali Vishal: Knowledge and attitude of clinical pharmacy facultytowards, and issues related to behind-the-counter drug program 84

Ballard Stephanie L: Meta-analysis of the tolerability of tapentadol204

Baniasadi Shadi: Isoniazid blood levels in patients with pulmonarytuberculosis at a tuberculosis referral center 163E

Baniasadi Shadi: The first pharmacist based warfarin monitoringservice in Iran 164E

Bansal Nidhi: Clindamycin induced acute kidney injury: Is this forReal? 473

Batel-Marques Francisco: Apixaban and rivaroxaban safety after hipand knee arthroplasty: a meta-analysis 166

Bates Madalyn: Implementation of telepharmacy services in amultihospital health-system 297

Becker Michael A: Febuxostat (FEB) vs. allopurinol (ALLO) intreating the hyperuricemia of gout in diabetic patients 254E

Berger Jeffery S: Meta-analysis of the relationship between aspirindosing and efficacy and bleeding outcomes in medically managedpatients with acute coronary syndromes (ACS) 33

Bergman Scott J: Simultaneous versus sequential combination therapywith vancomycin plus rifampin for Staphylococcus aureus biofilminfections 145

Bergman Scott J: Tigecycline use and selection of Pseudomonasaeruginosa 155

Besece Dina: Daptomycin use in neutropenic patients withdocumented MRSA bacteremia with high vancomycin MICs 152

Bhatt Prachi D: A comparison of patients with Klebsiella bacteremiawith imipenem-resistance to those with 3rd generationcephalosporin resistance 129

Bickley A Rebecca: Evaluation of a standardized magnesium sulfateinfusion protocol in aneurysmal subarachnoid hemorrhage 359

Biesboer Ann N: Retrospective analysis of unfractionated heparininfusions in obese patients 117

Biondi David: A post-hoc pooled data analysis to evaluate bloodpressure (BP) and heart rate (HR) measurements in patients with acurrent or prior history of hypertension who received tapentadolER, oxycodone CR, or placebo in chronic pain studies 202E

Biondi David: A post-hoc pooled data analysis to evaluate thegastrointestinal tolerability profile of tapentadol extended release(ER) versus oxycodone controlled release (CR) in patients ≥75years of age 201E

Bishop Jeffrey R: Risperidone-associated prolactin elevation andmarkers of bone turnover during acute treatment 244E

Bitton Bryce J: The combination of prothrombin complex concentrate,factor VIIa, and phytonadione to reverse elevated internationalnormalized ratio 90

Blaih Salah M: The quest towards personalized medicine: overview ofpharmacogenetics and safety of drug therapy 350

Bollmeier Suzanne G: Impact of unlimited access to asynchronousonline lecture viewing on student outcomes in a therapeutics course76

Bondar Anna: Ethnopharmacology comparison Nicaragua and Peru428

Bookstaver Davd A: Effect of CoEnzyme Q10 supplementation onHMG-CoA reductase inhibitor-induced myalgias 119

Bosley James R: PK/PD modeling and simulations supportdevelopment of MN-221, a novel, highly-selective �2-adrenergicagonist for treatment of acute asthma 243

Boudreau Samantha M: Assessing older adults’ knowledge of safemedication use and practices 407

Bourg Catherine A: Development of a medication therapymanagement service at a free clinic 291

Brackbill Marcia L: Adjunctive sitagliptin therapy in postoperativecardiac surgery patients: a pilot study 321

Bress Adam P: The effect of epithelial sodium channel genotype onloop diuretic requirements in systolic heart failure; interim analysisof the first 50 subjects 381

Bridgen Christine M: Does in vitro resistance of Streptococcuspyogenes to erythromycin produce clindamycin resistance? 372

Broders Jennie: COPD free medication initiative 323

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Brunetti Luigi: Association between vitamin D deficiency and diabeticretinopathy in the Third National Health and Nutrition ExaminationSurvey 99

Bryant Jacquelyn E: A retrospective cohort study on the use ofdexmedetomidine in patients with traumatic brain injury 405

Buchanan Melissa: Analysis of wait time disparities in the emergencydepartment for patients reporting with a chief complaint of chestpain from 2003 to 2008 396

Burckart Gilbert J: Comparison of pediatric versus adult safety studiesfor drug approval of antiviral and antipsychotic agents 208

Burke Stuart L: Renin and B-type naturetic peptide geneticpolymorphisms and association with response to aliskiren in heartfailure patients 460

Bush Mark: The effects of repeat doses of albiglutide on thepharmacokinetics and pharmacodynamics of a low-dose oralcontraceptive containing norethindrone and ethinyl estradiol 237

Butera Anne M: Evaluation of CHF patients not prescribed anACE/ARB in a family medicine residency Setting 421

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Cabrera Marie Jett V: Promoting sustainability: advocating theimplementation of a community-based, self- managed, pharmacist-led diabetes care program in a coastal community in the Philippines457

Capehart Krista D: Collaborative health risk assessment andmanagement program between the university pharmacy clinic andcity employees 287

Carney Jessica C: Optimizing heparin dosing in patients with cardiacarrest undergoing therapeutic hypothermia 306

Cavallari Larisa H: Association of the gamma-glutamyl carboxylase(CAA)16/17 repeat polymorphism with higher warfarin doserequirements African Americans 219

Chan Alexandre: Impact of antiemetic regimens adherence on nauseaand vomiting control among Asian breast cancer patients receivinganthracycline-based chemotherapy 180

Chan Alexandre: Prevalence of the co-prescription of interacting drugcombinations in cancer patients in Singapore 216

Chan-Tompkins Noreen H: Ertapenem monotherapy versuscefotetan/metronidazole combination therapy in colorectal surgerypatients 141E

Chandra Rachel N: Effectiveness of a pharmacist managedhypertension shared medical appointment 475

Chen Jack J: Rasagiline and antidepressant use in patients withParkinson’s Disease: assessing the occurrence of serotonin toxicity178E

Chhim Rebecca F: Evaluation of vancomycin use for pediatricStaphylococcal infections 210

Chiu Holly H: Malignancy and warfarin-mediated anticoagulation:lower initial dose requirements, but greater long-term instability,adverse events, and intensity of management 16

Cieri Nicole E: Obesity affects time to INR≥1.5 in surgical orthopedicpatients initiated on warfarin for venous thromboembolismprophylaxis 111

Clairmont Megan A: Outcomes associated with enoxaparin use amongpatients with varying renal function 115

Cleary John D: Pepper mould contamination risk toimmunocompromised 265

Clements Jennifer N: Endocrine and Metabolism PRN updates andreport of the benefit with an online journal club 191

Coley Kim: Student-created public service announcements: a novelapproach to attaining public health competency in the pharmacycurriculum 75

Congdon Heather B: Impact of a medication therapy managementprogram on hemoglobin A1c values in a health resources andservices administration patient safety and clinical pharmacyservices collaborative 20

Connor Sharon E: Homeless and housed patients’ access to treatmentat a pharmacist-led smoking cessation clinic 15

Coppenrath Valerie A: Pre-pharmacy biomedical literature experience:a survey of pharmacy student self-perception and ability to identifyliterature types 86

Crabb Katherine M: Simvastatin safety pharmacist intervention study436

Cribb Ashley H: Becoming an author during your residency:pharmacy resident publication rates and trends (2005-2010) 414

Cribb Ashley H: Treatment of fever during the acute stroke period at aprimary stroke center 444

Cronic Lydia: Angiogenic and vasculoprotective potential ofangiotensin receptor antagonists in the brain 450

Culley Colleen M: Off-label, low-dose ketamine as an effectiveadjunctive therapy for postoperative analgesia 199

Currie Janna L: North Carolina pharmacists’ practices and opinions ofsmoking cessation counseling 409

- D -

D’Antonio Nicole: Evaluation of an electronic health record warfarindocumentation system within a family medicine residency program365

Dager William: Determining optimal vitamin K dosing to reverseanticoagulation based on baseline INR, route of administration, andhome warfarin dose 118

Dager William: Evolution of an inpatient antithormbosis serviceincluding adaptation to the EPIC system and workload assessment329E

Dasta Joseph: Bupivacaine extended release liposome injection(DepoFoam® bupivacaine) vs. bupivacaine HCl: A meta-analysisof multimodal trials of doses up to and including 300 mg 198

Dasta Joseph: Evaluation of the hospital resource utilizationassociated with tolvaptan usage among heart failure patients withhyponatremia from the Everest trial 213E

Dasta Joseph: Trends in hyponatremia management and associatedoutcomes in hospital settings: Interim results from an observational,prospective, multi-center, global registry in hospitalized patients95E

Davis Kristen J: Utilization of home telehealth monitoring with activemedication management by clinical pharmacists in poorlycontrolled diabetic patients 94

Davis Susan L: Treatment of urinary tract infections: arecephalosporins associated with failure? 142

Davis Whitney L: A retrospective descriptive study of combinationantifungal therapies in pediatric oncology patients 455

Deal Eli N: Implementation of a standardized computerized physicianorder entry set for warfarin reversal improves evidenced-basedadministration of vitamin K 110

Devlin John W: Impact of quetiapine on the resolution of individualdelirium symptoms: An a priori-designed analysis of a randomized,double-blind, placebo-controlled study 57E

Dobesh Paul P: A comparison of management strategies in patientswith acute coronary syndrome based on clopidogrel use 37

Dougherty Tanya M: Incorporating pharmacy services within a familymedicine residency home visit program 322E

Douglass Mark A: Impact of a web-based learning module and facultypreceptor on experiential pharmacy students’ pain managementconfidence and competence 67

Dowling Thomas C: GFR equations overestimate oreatinine olearancein elderlyindividuals enrolled in the NIA-Baltimore LongitudinalStudy on Aging (BLSA) 102

Drozda Katarzyna: Association between the CYP2C9*8 variant andwarfarin clearance in African Americans 459

Durand Cheryl R: Assessing the appropriateness of proton pumpinhibitor utilization in hospitalized elderly patients 104

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Earl Grace L: Effectiveness of dietary sodium intervention providedby a clinical pharmacist to ambulatory patients with heart failure 13

Eckburg Paul B: FOCUS 1 and 2: Analysis of clinical response at Day4 from 2 phase III trials of ceftaroline fosamil vs ceftriaxone in thetreatment of community-acquired pneumonia 147E

Eckel Stephen F: Development of an automated tool to documentclinic-based pharmacists’ activities 288

El Hajj Maguy S: Community pharmacists in the state of Qatar: asurvey of their smoking cessation knowledge and educationalinterests 71

El Hajj Maguy S: Pharmacy students’ attitudes toward pharmaceuticalcare in Qatar 72

El Hajj Maguy S: Qatar pharmacists’ understanding, attitudes, practice


and perceived barriers related to providing pharmaceutical care 190 El Hajj Maguy S: Smoking cessation counseling in the state of Qatar:

community pharmacists’ attitudes and practices 44 Elder Jodie L: Title: West Michigan Glycemic Collaborative

(WMGC): Improving inpatient glycemic control and transition ofcare through interdisciplinary, inter-institutional collaboration 215

Elder Joshua J: Characterization of cannabinoid usage in a pediatriconcology population 211

Elewa Hazem F: Majority of patients treated with warfarin for atrialfibrillation are willing to switch to dabigatran 112

Elliott Tracy S: Tranexamic acid and decreased blood utilization 277 Elsasser Gary N: Identifying an optimal dose of vancomycin in

morbidly obese patients 134 Ensom Mary HH: Drug monitoring system in interstitial fluid: a

preliminary study of vancomycin and tacrolimus drugconcentrations 226

Ensom Mary HH: Pharmacokinetics of mycophenolic acid andglucuronidated metabolites following mycophenolate mofetil andmycophenolate sodium dosing in pediatric renal transplantrecipients 205

Ensor Christopher R: Impact of rituximab on donor specific antibodyburden in solid organ transplant recipients 267

Eschenauer Gregory A: Pseudomonas aeruginosa (PSA) combinationantibiogram: incorporating pharmacodynamic breakpoints (PDB) toidentify most appropriate empiric regimens 135

- F -

Fagan Susan C: Vascular protection with candesartan: beyond bloodpressure reduction 232

Falcione Bonnie A: Development and evaluation of a rubric to assessvalue of student WIKI contributions 89E

Falcione Bonnie A: Improving prescribing and documentation ofimmunization and education in patients who undergo emergencysplenectomy 153E

Fan-Havard Patty: Computer algorithm: a more sensitive tool thanstandard visual scoring for analyzing immunohistochemistrystaining of the placental vasculature 472

Farinde Abimbola: Effects of pharmacist drug regimen reviews onphysicians’ compliance with recommended laboratory monitoringcriteria for psychotropic medications at a state supported livingcenter 486E

Farkas Andras: Population probability of target attainment ofTelavancin at different levels of renal function against MethicillinResistant Staphylococcus aureus in US Medical Centers 221

Farrell David J: Spectrum of activity of ceftaroline/NXL104 and b-lactam comparator agents tested against methicillin-resistantStaphylococcus aureus carrying different SCCmec types and gram-negative bacilli with well-characterized resistance mechanisms139E

Feinstein Helen: Warfarin monitoring by pharmacists versus usualstandard of care in a long-term acute care hospital 298

Ferguson McKenzie C: The prevalence and quality of noninferioritystudies in major medical journals 60

Ferreira da Silva Sebastião: Pharmaceutical appointment in clinicaltrials 341

Finch Christopher K: An evaluation of the management of non-lifethreatening COPD exacerbations in hospitalized patients 252E

Fink Jodie M: Comparison of calcineurin inhibitor administrationpost-heart transplantation 268E

Fiuzat Mona: Influence of global region on outcomes in large heartfailure b-blocker trials 40E

Flowers Stephanie A: Sterol uptake in Candida albicans: a novelmechanism of fluconazole resistance 333

Forinash Alicia B: Low molecular weight heparin use in the pregnantpopulation 273

Foster Megan E: Intranasal fentanyl and midazolam use in a pediatricemergency department 93

Foster Megan E: Retrospective review of NPO status in childrenreceiving ketamine for procedural sedation in the emergencydepartment 91

Fox Jeremy: Evaluation of newer equations for estimation of renalfunction for utility in drug dosing using an aminoglycosidepharmacokinetic model 240

Frazee Erin N: Incidence of hyperglycemia in at risk medical intensivecare unit patients upon cessation of intravenous insulin infusions357

Freytag Rachel L: The use of valproic acid or oxcarbazepine to treatdementia-related agitation 366

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Gabardi Steven: Efficacy and safety of six months of low- vs. high-dose valganciclovir for prevention of cytomegalovirus disease inhigh-risk renal transplant recipients 160

Garner Melinda D: The effect of haloperidol loading dose on theduration of delirium 367

Garwood Candice L: Chronic kidney disease and anticoagulationinstability in warfarin-treated patients: insights into potentialtreatment strategies 113

Gauld Andrea R: Assessment of insulin pens in an urban teachinghospital outpatient clinics 14

Genovese Mark C: Long-term safety of tocilizumab in rheumatoidarthritis clinical trials 256E

Gerlach Anthony T: Blood pressure control in the hospitalized elderlytrauma population 358

Gerrald Katherine R: Pharmacist-managed diabetes service in a ruralfree clinic 286

Ghamrawi Riane J: Identified drug therapy problems in a federallyqualified health center 390

Ghodrat Mandana: Evaluation of an improved warfarin dosingguideline used by an inpatient pharmacy-managed anticoagulationservice compared to physician’s dosing 328

Giannakos Maria: Utilization of cloud computing to aid experientialprecepting at a tertiary academic medical center 314

Gillis Louise-Marie: Evaluating dosing of erythropoiesis-stimulatingagents on hemoglobin levels in bloodless medicine patients 51

Giuliano Christopher A: Are proton pump inhibitors associated withthe development of community acquired pneumonia: a meta-analysis 100

Gleason Tara E: Use of low molecular weight heparin (LMWH) inpregnancy: a pharmacodynamic modeling study 17

Goldberg Stuart: Association between chronic myeloid leukemiatreatment responses and patient satisfaction, functioning, andquality of life: patient survey results 184E

Gonyeau Michael J: Economic evaluation of clinical interventionsfrom an integrated internal medicine and ambulatory care APPE 77

Gorospe Gerry: ENESTnd 24-month follow-up of nilotinib versusimatinib in patients with newly diagnosed chronic myeloidleukemia in chronic phase 182E

Gow James A: Bepotastine besilate ophthalmic solution 1.5% rapidlydemonstrated near clearance of ocular itch in the conjunctivalallergen challenge model of allergic conjunctivitis 196E

Gow James A: Bepreve (bepotastine besilate ophthalmic solution)1.5% improves reflective ocular itching scores in a placebo-controlled natural exposure study of subjects with a demonstratedhistory of seasonal allergic rhinoconjunctivitis (SAR) 197E

Gow James A: Bromfenac ophthalmic solution for treating the signs ofdry eye disease 193E

Gow James A: Integrated phase 3 clinical trials of bromfenac sodiumophthalmic solution dosed once daily for ocular surgery 194E

Gow James A: The ocular comfort of bepotastine besilate ophthalmicsolution 1.5% in a safety clinical trial 195E

Groo Vicki L: Determinants of worsening renal function with diureticdose escalation in a chronic heart failure ambulatory population 39

Groth Meghan E: Increased frequency and duration of elevated bloodpressure measurements after IV thrombolytics for ischemic strokeis not associated with increased risk of symptomatic intracerebralhemorrhage 179

Guarascio Anthony J: A matched-controlled evaluation of anantifungal bundle in the intensive care unit at a university teachinghospital 373

Guerin Annie: Adherence patterns and dose adjustments with second-line nilotinib and dasatinib in patients with chronic myeloidleukemia: evaluation in a real-world setting 185E

Gupta Nishi S: Evaluation of patient education on preventive healthmeasures and poison control center awareness during senior brownbag medication reviews 424

447e


Gupta Nishi S: Patient satisfaction and self-perceived knowledgegained during senior brown bag medication reviews 425

- H -

Ha Belinda F: Efficacy and safety of abacavir/lamivudine plusraltegravir at week 96 in antiretroviral-naive HIV-1-infectedpatients in the SHIELD study 122E

Ha Belinda F: Switch to fosamprenavir with addition of lovaza formanagement of hypertriglyceridemia in HIV-infected patients onboosted protease inhibitor regimens: a pilot study (BuLLET) 124E

Haas Curtis E: Relative bioavailability of oral fosphenytoin sodiuminjection in healthy volunteers 231

Hagopian Jennifer C: Bleeding rates among patients with morbidobesity treated with enoxaparin 116

Haines Stuart T: Ready and willing: a self-assessment tool todetermine student pharmacists’ confidence to optimize drug therapy61

Hall Deanne L: Identification of reasons for discontinuation ofdabigatran in an outpatient cardiology office 427

Halton Kimberly: Characteristics of patients with de-escalatedantibiotics based on culture and sensitivity data: impact on hospitalre-admittance 149

Hamby Christine: The impact of a gentamicin-citrate catheter lockintervention on outpatient hemodialysis catheter-associatedbloodstream infections 136

Hanania Nicola A: The safety and efficacy of roflumilast: a newtreatment to reduce exacerbation risk in severe COPD patients 251

Haney Jason S: Assessing the effect of multiple advanced cardiac lifesupport simulations on pharmacy student performance 310E

Hanselin Michele R: Description of antihypertensive use in patientswith resistant hypertension prescribed four or more agents 30

Harrison Chelsea M: Building a curriculum to combat obesity inelementary schools 411

Hartung Daniel M: Alternative methods for disseminating evidence-based prescription drug information among primary care cliniciansin rural Oregon: The rural Oregon academic detailing (ROAD)project 108

Helmer Robert S: Use of an adherence estimator and individualizedcounseling for new chronic medication prescriptions 364

Herring Holly: Identifying and removing usage barriers of infusionsmart pumps 171

Herring Holly: Impact of pharmacist involvement at discharge oncompliance with The Joint Commission heart failure core measure41

Hilas Olga: Clinical interventions of pharmacy practice residents onan acute care for elders unit 484

Hilas Olga: Pursuit of post-graduate training programs upongraduation 481

Hill Robin R: Improving documentation of the value of clinicalpharmacy interventions in an integrated healthcare delivery system335E

Hofmann Prudence: Compliance with NASPE monitoring guidelinesfor amiodarone 168

Hoie Eric B: New dosing recommendations for vancomycin inpremature infants 138

Hollands James M: Continuous neuromuscular blockade and train-of-four monitoring in patients treated with therapeutic hypothermia 49

Holm Michelle: Development of a pharmacy computerized inventoryprogram (PCIP) in an emergency department/intensive care unit,outpatient care, and a pediatric hospital in Haiti 483

Hope Charlene A: Evaluation of medication reconciliation forinpatients with uncontrolled diabetes: preimplementation study 274

Horbowicz Karen M: Implementation of a herpes zoster immunizationservice at an independent community pharmacy 300

Horn Edward T: Evaluation of a pre-emptive strategy for CMVdisease prevention in cardiac transplant patients 258

Horn Paula: Evaluation of pharmacist-run anticoagulationmanagement service of ventricular assist device (VAD) patients292E

Hudson Joanna Q: Effects of a-lipoic acid on oxidative stress in ESRDpatients receiving IV iron 177E

Hudson Joanna Q: Evaluation of antibiotic prescribing patterns inpatients receiving sustained low-efficiency dialysis 133

Hudson Joanna Q: Evaluation of the MDRD and Cockroft-Gaultequations for sitagliptin dosing 176E

Hughes Ashley R: Initial stages in the development of anantimicrobial stewardship program in a teaching hospital 326

- I, J -

Ipema Heather J: Evaluation of risk factors for warfarin resistancefollowing administration of vitamin K 172E

Jennings Douglas L: Left-ventricular assist device implantation doesnot alter the pharmacodynamic response to warfarin 27

Jennings Douglas L: Opportunities for clinical pharmacist interventionin the pharmacotherapy of patients with left-ventricular assistdevices 293

Jennings Phillip: Pharmacokinetic interactions of roflumilast withmedications commonly prescribed for COPD patients 236E

Jeppson Patricia A: Effects of standardization of urine alkalinizationfor hematology and oncology patients 339

Jernigan Meredith: Assessment of antibiogram use in patients withsepsis transferred to a tertiary care facility 150

Jernigan Meredith: Doripenem and colistin is synergistic anddemonstrates bactericidal killing against pandrug-resistantKlebsiella pneumonia isolates in vitro 374

Jessmer Jill: Use of the clinical pulmonary infection score (CPIS) toguide duration of antibiotic therapy in Medical Intensive Care Unit(MICU) patients with healthcare-associated pneumonia (HCAP)332

Jodlowski Tomasz Z: Comparison of online drug interaction databasesto evaluate antiretroviral medication interactions 1

Jodlowski Tomasz Z: Implementation of medication reconciliation bya pharmacist in patients with human immunodeficiency virus oracquired immune deficiency syndrome on highly activeantiretroviral therapy 165

Johnson David: Preservation of renal function with angiotensinconverting enzyme inhibitor or angiotensin receptor blockertherapy early after heart transplantation 387

Johnson Heather J: Expanding residency opportunities through schoolof pharmacy collaborations 313

Johnson Heather J: Use of HMG-CoA reductase inhibitors in livertransplant patients with recurrent Hepatitis C Virus 266

Johnson Jessica L: Pseudoephedrine for neurogenic shock after acutespinal cord injury 304

Johnston Curtis: Attenuation of vancomycin pharmacodynamics (PD)due to dense inoculum methicillin-resistant Staphylococcus aureus(MRSA) 467

Jones Ashley E: Management of Stenotrophomonas maltophilia inpediatric patients: a retrospective evaluation 432

Jones Peter H: Lipid target attainment by switching statinmonotherapy to fenofibric acid + statin in patients with mixeddyslipidemia and at high-/highest-risk for coronary heart disease21E

Jones Terreia: Thiopurine-associated tumorigenesis: using thiopurinemethyltransferase to identify important thioguanine-inducedphenotypes in astroglial cells 189

Jonkman Lauren J: A pharmacist-run collaborative care program in afree urban primary care clinic 282

Juang Paul: Empiric anti-MRSA antibiotics for MRSA pneumonia in acommunity hospital 156

- K -

Kallash Hanan: An NIH-sponsored pharmacist curriculum oninterventions for Sudden Infant Death Syndrome (SIDS) riskreduction 209E

Kalus James S: Creation of a risk score for predicting opioid harm inthe inpatient setting 377

Kane-Gill Sandra L: Severity and preventability of drug-inducedhypotension 47E

Kann Colleen S: Evaluation of pharmacist decision making andopinions involving prescriptions with a high probability of causingpatient harm 173

Kar Indrani: Do differences between quantitative viral plaque assaysexplain variability among pre-clinical respiratory syncytial virusstudies in animals? 430

Karaoui Lamis: Implementation of and experience with a locally-


developed summative exit exam delivered to PharmD students priorto graduation 73

Karr Samantha: Assessing interest in clinical pharmacy serviceswithin a unique community setting 389

Kashyap Anita: A comparison of survey methods on vitamin, herbal,and over-the-counter product use in patients with heart failure 394

Kauffman Yardlee S: Identifying medication-related needs of HIVpatients: foundation for communitypharmacist-based services 301E

Kays Michael B: Evaluation of clinical outcomes and adverse eventswhen administering alternative doses of linezolid to obese patients154

Kays Michael B: Pharmacokinetics and pharmacodynamics ofmeropenem in morbidly obese, hospitalized patients 158

Kays Michael B: Pharmacokinetics and pharmacodynamics ofpiperacillin/tazobactam administered by prolonged infusion inmorbidly obese, hospitalized patients 143

Kelly Maureen T: Long-term efficacy and safety of fenofibric acid incombination with statins in patients with mixed dyslipidemia andtype 2 diabetes mellitus 22E

Kendrach Michael G: Faculty development activities in US pharmacyschools 85

Kharidia Jahnavi: Exposure-response analysis of eslicarbazepineacetate adjunctive treatment of patients with partial-onset seizures223

Kharidia Jahnavi: Population pharmacokinetics of eslicarbazepineacetate in patients with partial-onset seizures 224

Kiang Tony KL: Drug monitoring system in interstitial fluid:feasibility studies of valproic acid, methotrexate, gentamicin, andtheophylline 225

Kim Jenny J: Evaluation of an ipad to provide warfarin videoeducation in the inpatient setting 7

King S Travis: Analysis of outcomes and risk factors associated withextended-spectrum �-lactamase-production in bloodstreaminfections 157

King S Travis: Pharmacokinetic and safety analysis of high-dosemoxifloxacin in a morbidly obese individual 159

Kipp Gretchen: Tacrolimus trough concentrations in heart transplantrecipients during episodes of acute cellular rejection 383

Klepser Michael E: Evaluation of a community pharmacy-basedinfluenza screening and management program versus pharmacyscreening and referral to standard of care 42

Ko Yuan-Hsun: Pharmacist-led and interdisciplinary model formanagement of adult cancer pain in a medical center 343

Koerner Pamela H: Examining utilization patterns of patientsreceiving oral therapy for multiple sclerosis (MS) treatment 379

Kolehmainen Natalie J: Patients’ perception of clinical pharmacyservices in a federally qualified health center 391

Korobey Matthew J: Pharmacy department commitment to amultidisciplinary stroke response team 11

Krahe Dombrowski Sarah E: Impact of community pharmacyexperience in a family medicine residency (student poster) 412

Kruse Jaclyn A: Evaluation of an interprofessional approach toteaching medication therapy management (MTM) 406

Kuo Grace M: Medication errors reported by US clinical pharmacists:the ACCP PBRN MEDAP study 170

- L -

Laizure S Casey: Synuclein gene microsatellite length associated withalcohol and cocaine addiction 257

Lamp Kenneth C: Experience with daptomycin for coagulase-negativestaphylococcal bacteremia with elevated vancomycin MICs 151E

Lamp Kenneth C: Viridans group streptococci treatment withdaptomycin: multinational experience 148E

Lancaster Jason W: A retrospective review of medication ordersentered for emergency department patients within an academicteaching medical center for quality assurance 317

Lancaster Jason W: Perception of advanced pharmacy practiceexperience students on inpatient internal medicine rotations: ahealthcare provider perspective 64

Lanham Kena: Clinical pharmacy technicians: impact in cardiologyand critical care pharmacy services 296

Lansangan Pio Juan: Inpatient management of warfarin therapy bypharmacists compared to physicians 395

Law Amy W: The impact of possible undiagnosed heavy menstrualbleeding (HMB) on presenteeism and activities outside of work 214

Le Thy: Candidemia pharmacotherapy over eight years at a tertiarymedical center 127

Leaders Edward D: Improving adherence to an intensive care unitsedation protocol and effects on patient outcomes 56

Leandro Ana: Carbapenems selection by means of the SOJA method308

Leandro Ana: Cost-efficacy analysis of pemetrexed in first-linetreatment of non-small cell lung cancer 348

Lederhouse Lisa: Impact of a pharmacist sedation program on themedical and surgical mechanically ventilated patient population in alevel II trauma center 54

Ledford Travis: Predictors of mortality among elderly patients withGram-negative bloodstream infection 128E

Lee Hye-In: CYP2D6*10/*10 genotype significantly affected thepharmacokinetics of tamsulosin 464

Lee Seok-Yong: Effect of CYP2D6*10 allele on the pharmacokineticsof propranolol in Koreans 465

Lee Seok-Yong: Effects of CYP2D6*10/*10 genotype on thepharmacokinetics of metoclopramide 463

Lee Tzu-Ying (Yasmina): Impact of a pharmacist-managed diabetesclinic on glycemic control using concentrated U-500 regular insulin281

Leibowitz Mark T: Bioequivalence of immediate-release oxycodonewith Aversion® Technology (IRO-A), IRO-A with niacin, and acommercially available oxycodone 227E

Leitz Gerhard J: A multi-center, double-blind, parallel-group study toevaluate short-term safety and efficacy and long-term maintenanceof two dose levels of rabeprazole sodium delayed-release pediatricbead formulation in 1 to 11 year-old pediatric subjects withEndosco 101E

Lepage Jayne E: The process of assessing student performance; iscreating a rubric the answer? 79

Lepak Maryjoy R: Hemodynamic targets and vasopressor use inneurogenic shock 404

Leu Wuan-Jin: Impact of pharmacist-led antimicrobial stewardshipusing a computerized system with prospective audit and feedbackapproach in a university hospital 106

Lindsay Caroline A: Medications associated with delirium inhospitalized subjects 443

Linnebur Sunny A: A pilot fee-for-service medication therapymanagement program in a geriatric primary care clinic 325

Lipari Melissa: As needed intravenous antihypertensive therapy andblood pressure control 10

Llanos Samantha R: Assessing the impact of an introductorybiopharmaceutical industry elective on student rotation preferencesand career choices 363

Lo-Ciganic Wei-Hsuan: Can the risk of ovarian cancer be reduced bythe use of aspirin, non-aspirin nonsteroidal anti-inflammatorydrugs, or acetaminophen? A large population-based case-controlstudy 217

Loebel Antony: Lurasidone pharmacokinetics: assessment of thepotential for drug-drug interactions 229

Lohr Brian R: Assessment of fluoroquinolone-resistant urinarypathogens in patients admitted to an acute care hospital from anursing home 132

Lyons Kayley M: A mentoring program for clinical and operationsupervisors 397

-M -

Mack Diana R: Evaluation of infusion-related reactions with ironsucrose at a large tertiary medical center 485

MacKay Kimberly: Effect of implementing an electronic order menufor trimethoprim-sulfamethoxazole on changing prescriber orderingbehavior and decreasing adverse events in elderly outpatientveterans 161

Maier Gary: Drug-drug interaction of eslicarbazepine acetate withantiepileptic drugs 222

Malcom Daniel R: Prospective evaluation of student-led presentationsas a successful teaching method for achieving critical carecompetency 68

Malone Margaret: Impact of change in duration of therapy with

449e


Ursodiol after gastric bypass surgery 12 Mankoski Raymond: Antipsychotic adherence and discontinuation

outcomes in schizophrenia patients with metabolic comorbidities:analysis of 24 state Medicaid programs 245

Marcotullio Nicole: Utilization of IPads to facilitate data collectionduring pediatric screening events 392

Mariani Nicholas P: Financial impact of a community pharmacy basedanticoagulation service 400

Mark Liana: Gentamicin pharmacokinetics in neonates undergoingtherapeutic hypothermia 207

Marlowe Karen: Pharmacists perceptions and knowledge regardingopioid risk evaluation and mitigation strategies (REMS) incommunity and ambulatory practice 203

Marrs Joel C: Increased goal attainment after conversion fromrosuvastatin to simvastatin in a community health clinic 18

Marshall Janene L: Argatroban dosing evaluation amongst medicalpatients in a community hospital 276

Matthews Michele L: An interdisciplinary approach to reducing opioidanalgesic misuse in patients with chronic noncancer pain in theprimary care setting 344

Mauro Michael: A survey of current practices in the management ofchronic myeloid leukemia 186E

McBride Ali: A comparative evaluation of single fixed-dosing andweight-based dosing of rasburicase for tumor lysis syndrome 327

McConaha Jamie L: Assessing community pharmacist impact on over-the-counter medication selection 303E

McConaha Jamie L: Community pharmacist clinical documentationintervention project 299

McConaha Jamie L: Improving health outcomes and continuity of carein underserved, urban populations 399

McConeghy Kevin W: Effect of home �-blocker use in patientspresenting with subarachnoid hemorrhage 52

McEwen Corey L: Lack of association between statin therapy andtestosterone deficiency 439

McKenzie Christina: Student college of clinical pharmacy providescommunity service for the Akron Area Agency on Aging 416

Mehta Bella H: Evaluation of student pharmacists’ awareness andperceptions of board certification 74

Mersfelder Tracey L: BA4LL: Bounce around 4 larger learning.Utilization of exercise balls for chairs on an internal medicineAPPE 66E

Metzger Nicole L: Incidence of supratherapeutic troughconcentrations in elderly patients with aggressive vancomycindosing 331

Meyer Allison: A multi-center characterization of antipsychotic use forthe treatment of delirium in medical ICU patients 403

Meyer Susan: Teaching emphasis within pharmacy residencyprograms 360

Meyer Susan: Using standardized colleagues to developinterprofessional communication skills 81E

Miller Monica L: Creation of a global health pharmacy residency inKenya 312

Mills Keri L: Post-FDA safety statement medication use evaluation ofrosiglitazone 438

Min David: The association between NF-kB gene polymorphisms andallograft survival in the Hispanic kidney transplant population 462

Mitchell Amy: Improved safety of intermittent infusion delivery in theneonatal intensive care unit: establishing a need for thestandardization of medication administration 456

Mohammad Rima A: Impact of hospital-based pharmacist advocatesin care transitions: identification and description of medicationrelated interventions after patient discharge from hospital to home278

Momary Kathryn M: Critical literature evaluation and advancedpharmacy practice experiences: student preparedness 316

Momary Kathryn M: The implications of clopidogrel black boxwarning on utilization of platelet aggregation testing in thecommunity hospital setting 295

Momper Jeremiah D: Clinical pharmacokinetics of low-dose cidofovirwithout and with concomitant probenecid used for the treatment ofpersistent BK viremia in renal transplant recipients 241E

Montgomery Jamie: The role of a community pharmacy resident inexpanding clinical pharmacy services within a traditional

dispensing model 302 Murphy John E: Student perceptions of large scale interprofessional

education events 82

- N -

Nagappa Anantha Naik: Drug-related problems with antidepressants ina hospital setting in India 351

Naim Ahmad: Examining knowledge and information seekingbehaviors towards blood transfusion among individuals withChronic Kidney Disease 345

Naim Ahmad: Examining the patient-centered decision makingattributes towards blood transfusion among individuals withChronic Kidney Disease (CKD) 346

Nazer Lama H: Incidence, characteristics, and outcomes of adversedrug events resulting in intensive care admission in oncologypatients 3

Neal Erin: The role of computerized clinical decision support inreducing inappropriate medication administration during epiduraltherapy 167

Neill Jennifer L: Changes in RIFLE criteria after coronary arterybypass graft surgery in patients with recent exposure to angiotensinconverting enzyme inhibitors and angiotensin receptor blockers 35

Nelson Matthew S: Benchmarking enoxaparin use in the emergencydepartment as a quality improvement metric for clinical pharmacyservices 319

Newton Michael: Current state of teaching oncologypharmacotherapy: focus on cancer as a chronic disease 80

Nisly Sarah A: Dietary supplement education in a senior population 69 Nolin Thomas: Knowledge, perceptions and adherence of ESRD

patients receiving erythropoietic therapy and anemia management:A student-pharmacist based survey in an outpatient peritonealdialysis clinic 442

Nordstrom Beth L: Timing of venous thromboembolism followingtotal knee or hip replacement 114

Norgard Nicholas B: Compatibility of adenosine with iodinatedcontrast agents 230

Norgard Nicholas B: The antiplatelet effects of sustained-releaseniacin 24

- O -

O’Connell Mary Beth: Assessment of student pharmacist learningfrom a multidisciplinary older adult home visit 408

O’Connell Mary Beth: Classifications of drug related problemsdiscovered during senior brown bag medication reviews 423

O’Connell Mary Beth: Experiential value of an older adult medicationassessment early in the pharmacy curriculum 410

Oh Jung Mi: Effectiveness of palonosetron compared with the otherserotonin antagonists in combination with aprepitant in preventinghighly emetogenic chemotherapy induced emesis 447

Oh Jung Mi: Management of serum calcium and phosphorous levelsfor the prevention of mineral bone disease in chronic kidneydisease patients on dialysis by multidisciplinary team care 441

Olyaei Ali: Comparisons of enteric-coated mycophenolate sodium andmycophenolate mofetil outcomes from the Mycophenolic AcidObservational Renal Transplant Registry 261

Onel Erol: DepoFoam® Bupivacaine (DB; EXPAREL™; BupivacaineExtended Release Multivesicular Liposome Injection) exhibitspharmacokinetic properties consistent with sustained releasecharacteristics 200

Oschman Alex: Comparison of single dose arginine hydrochloride tomultiple doses of acetazolamide to correct metabolic alkalosis inpediatric patients 212

- P -

Pacheco María de la Paz: Selective decontamination in thecardiovascular intensive care unit: analysis of the consumption ofdifferent groups of antimicrobial agents 53

Paciullo Christopher A: Pharmacist publications in critical careliterature over a period of ten years 48

Padley Robert J: Aspirin reduces transient flushing and glucoseincreases during therapy with niacin extended-release 25E

Pakes Gary E: Pharmacokinetics, cord blood concentrations, andtolerability of boosted fosamprenavir in pregnancy 239E


Pallotta Andrea: Development, implementation, and assessment of apilot pharmacy vancomycin dosing service (PVDS) 330

Parma Jennifer M: Acneiform rash does not predict response toneoadjuvant lapatinib monotherapy in breast cancer patients 446

Patel Khusbu: Vancomycin serum levels and efficacy in methicillinresistant Staphylococcus aureus (MRSA) infections 370

Patel Nishil P: Evaluation of a diabetic ketoacidosis protocol toimprove quality and cost of care 275

Patterson Mark E: Associations between communication climate andthe frequency of medical error reporting among pharmacists withinan inpatient setting 107

Pearce Erica F: Role of a pharmacist in a patient-centered medicalhome for university employees 284

Perry Lisa M: Frequency of aminophylline use for reversal ofdipyridamole and regadenoson 294

Personett Heather A: Review of anidulafungin utilization in patientswith hepatic dysfunction at a large academic medical center 371

Pesaturo Adam B: Combining a clinical pharmacy economicintervention tool with an intervention documentation system 109

Pham Jacqueline T: Effects of dual blockade of the renin angiotensinsystem in diabetic kidney disease: a systematic review and meta-analysis 175

Phillips Jennifer: An analysis of medication errors associated with theuse of technology 338E

Phuong Lily: Evaluation of a fluticasone/salmeterol step-downprogram 375

Pierce Wesly A: Survey of heparin-induced thrombocytopenia (HIT)laboratory testing and evaluation of a tailored HIT screeningprotocol based on the 4Ts scoring system 307E

Pinchevsky Diana N: Blue genes: genetic variant of brain-derivedneurotrophic factor associated with depression index in post-coronary artery bypass graft patients 468

Poirier Therese: Assessment of students’ readiness for self-directedlearning 62E

Poloyac Samuel: Cytochrome P450 eicosanoid levels in cerebrospinalfluid and delayed cerebral ischemia in subarachnoid hemorrhagepatients 55

Popa Jennifer: Developing a Sentri7®-driven inpatient clinicalpharmacy service 398

Potts Lisa: Evaluation of two education methods for patientknowledge in patients recently started on warfarin 19

Prince Aaron J: Incidence and characteristics of antithrombotic errorsin the emergency department 92

Prokopienko Alex J: Differential effect of IV iron compounds onintracellular reactive oxygen species (ROS) generation in aorticcoronary endothelial cells 440

Prom Rathasen: Simvastatin amiodarone drug interaction alert:adherence to dosing recommendations before and after theimplementation of a new computerized drug-drug interaction alert355

Puschak Christine E: Pharmacists’ role in evaluation of “as necessary”medications at a community hospital 449

- Q, R -

Quinones Marissa E: Highlighting the work of the Ambulatory CarePRN in 2011 283

Rable Katherine J: Evaluation of a pharmacy-driven renal dosingprogram 8

Radwanski Przemyslaw: Blockade of sodium entry amelioratesarrhythmias during calcium overload 477

Rafie Sally: Evaluation of a pharmacist oversight program formedication use in the emergency department of an academicmedical center 320

Regen Sloan M: Gender disparities in authorship of original researchpublications in pharmacy journals 415

Relling Mary V: Dexamethasone systemic exposure is associated withhyperlipidemia in children with acute lymphoblastic leukemia 235

Ribeiro Rama Ana C: Standard operating procedure to developevidence-based information to support pharmacy and therapeuticscommittee decision for formulary management at a universityhospital 309

Riche Daniel M: Economic impact of ambulatory clinical pharmacyservices 349

Ripley Toni L: The impact of a clinical pharmacist on a cardiovascularsurrogate endpoint: A pilot study 29

Rogers Christin: Impact of conversion to sirolimus-based immuno-suppression on fibrosis progression in HCV+ liver transplantrecipients 487E

Rohde Kalynn A: Effectiveness and safety of influenza vaccine in firstsix months post-lung transplant 470

Rokas Kristina: Observational study of dexmedetomidine in traumacritical care patients 402

Rolfe Stephen: Evaluation of pharmacy resident perceptions,knowledge and interventions following a trauma response trainingprogram 480

Rolland Philip: Interdisciplinary approach to medication safety:collaborative care for developmentally disabled individuals 336

Rowe A Shaun: Nephrotoxicity associated with weight basedvancomycin dosing 233

Ryan Gina J: Medication reconciliation: comparing a customizedmedication history form to a standard medication form. (CAMPII2) 169

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Sader Helio S: Antimicrobial activity of ceftaroline combined withNXL104 tested against a collection of organisms expressingmultiple b-lactamases 140E

Sakely Heather A: Pharmacist-physician interdisciplinary facultydevelopment: get out of your silo! 315

Salinitri Francine D: The effect of basal-bolus insulin vs. sliding scaleinsulin on quality indicators in hospitalized patients with type 2diabetes mellitus on hemodialysis 98

Salvo Marissa C: Implementation of a pharmacist-led medicationreconciliation service in a federally qualified health center 289

Salvo Marissa C: Incorporating a clinical pharmacist on a medicalteam serving the homeless 290

San Roman Marie: Characterization of polymyxin B (PB) againstAcinetobacter baumannii using pharmacokinetic andpharmacodynamic (PK/PD) approaches 466

Saseen Joseph J: Persistent use of against label statin-fibratecombinations from 2003 to 2009 despite FDA dose restrictions 353

Schmidt Nicole M: 10-Year experience with early corticosteroidelimination in kidney transplantation: analysis of patient and graftsurvival 385

Schmidt Nicole M: Early corticosteroid withdrawal reduces risk foractual cardiovascular events in renal transplant recipients: amultivariate analysis 384

Schonder Kristine S: Impact of immunosuppressant regimen on theonset of hyperlipidemia in kidney transplant recipients 270

Scott James D: Comparison of clinical outcomes between ritonavir-boosted atazanavir and unboosted atazanavir in HIV patients on aregimen containing tenofovir 120

Scott James D: Effects of darunavir, ritonavir and darunavir/ritonaviron T-cell activation and apoptosis using HIV-negative CD4+lymphocytes 125

Scoville Bridget A: Comparison of short-term pulmonaryimprovement associated with inhaled nitric oxide and inhaledepoprostenol for acute respiratory distress syndrome 45

Sealy Patricia I: Surveillance of antibiotic resistance at a tertiaryinstitution in Trinidad 334

Selvage Jennifer T: Characteristics associated with clinical pharmacistinterventions among home-based primary care veterans 324E

Senbetta Mekre: Quality of life burden in chemotherapy-naïve andchemotherapy-experienced men with metastatic prostate cancer 347

Sevin Alexa M: Impact of a student-implemented patient educationcampaign 413

Shaefer Mark S: Changes in inflammatory biomarker levels andcorrelation with Framingham (FRAM) risk scores in antiretroviral-naive HIV-infected patients through 144 weeks ofabacavir/lamivudine-containing therapy in ARIES (EPZ108859)126E

Shaefer Mark S: Efficacy/tolerability of unboosted atazanavir versusatazanavir/ritonavir, each in combination with abacavir/lamivudine, after initial suppression with abacavir/lamivudine +atazanavir/ritonavir in HIV-1-infected patients: 144-week results ofARIES 123E

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Shaefer Mark S: Hepatic Safety profile of fosamprenavir-containingregimens in HIV-1-infected patients with or without Hepatitis C orB co-infection 121E

Shamroe Caitlin L: Adverse drug events secondary tosulfamethoxazole/trimethoprim in HIV–infected hospitalizedpatients 431

Sharma Bharti: Glyburide versus glipizide: a comparison of glycemiccontrol in a selected veteran population 6

Sharma Milan: The effects of adding liraglutide to an urban type 2diabetic population 419

Sharp Randall P: Lack of significance between use of statins andcardiovascular events in carriers of the Kinesin family member 6gene 719Arginine allele 28

Shaw Jennifer: Risks, rewards and the double-edged sword:pharmacogenetic testing and research in the AlaskaNative/American Indian community 218

Shen Li-Jiuan: Inadequate empirical vancomycin dose in non-elderlyneurosurgical patients by conventional dosing regimen 238

Shenoy Somanath PR: Candesartan for prostate cancer: A dose or aclass effect? 234

Sherman Rebekah E: Reimbursed medication therapy managementservices in a community health center for a Medicare population285

Shields Adele R: A prospective, single center, pilot study ofpretransplant thymoglobulin administration and early corticosteroidwithdrawal in living donor renal transplant recipients 264

Shields Adele R: Cardiovascular events and CV-related mortality afterrenal transplantation: effect of maintenance steroid therapy andpreexisting coronary artery disease 269

Shields Adele R: Steroid-free, calcineurin inhibitor minimizingregimen with long-term mycophenolate mofetil monotherapy forHLA identical living donor kidney transplantation: long-termoutcomes 263E

Shin Jaekyu: Comparative effectiveness of endothelin receptorantagonists for the treatment of pulmonary arterial hypertension (APilot Study) 34

Shirk Mary Beth: Insulin based glucose control audit for emergencydepartment observation unit patients 417

Shogbon Angela O: Communication of clinical recommendationsduring patient case-based cardiovascular therapeutics oralexaminations 78

Shogbon Angela O: Patient-focused pharmacotherapy notes in acardiovascular therapeutics course: a standardized approach 70

Sims J Jason: Dose escalation of �-blocker therapy followinginitiation of cardiac resynchronization therapy 23

Skibowski Amanda: Risk for medication non-adherence and otherdrug therapy problems among ambulatory patients in a safety-nethealth-system 393

Smallwood Gregory: Is valganciclovir a viable option forcytomegalovirus (CMV) prophylaxis in liver transplantation? 272

Smith Andrew: Assessment of the prevalence, structure and functionof “informal” student chapters of ACCP 482

Smith Curtis L: Using non-bronchoscopic bronchoalveolar lavage-obtained respiratory cultures to guide antimicrobial therapy inpatients with suspected pneumonia 305

Smith Judith A: Evaluation of adverse drug events associated withliposomal doxorubicin in patients with renal insufficiency treatedfor gynecologic malignancies 188

Smith Judith A: Evaluation of gemcitabine modulation of multidrugresistance in cisplatin resistant human ovarian cancer cell line 187

Smith Lonnie: African American renal transplant one year outcomesfrom the Mycophenolic Acid Observational Renal TransplantRegistry 262

Smithburger Pamela L: Comparing the type and severity of druginteractions among different ICUs 2

Soong Karen: Impact of a pharmacist as a member of aninterprofessional team to identify and reduce medication relatedproblems during transitions of care from skilled nursing facilities(SNFs) to home 422

Spinler Sarah: National Cholesterol Education Program (NCEP) lipidgoal achievement beyond low-density lipoprotein cholesterol(LDL-C) in patients with diabetes mellitus (DM): focus on non-high density lipoprotein cholesterol (nonHDL-C) in the practice

innovation and Cl 36 Spycher Martin O: Investigation of potential neurological effects of

stabilizers used in immunoglobulin products: comparison of prolineand glycine 337E

Steele Savanna: Endothelial nitric oxide synthase polymorphisms andendothelial function in coronary artery disease patients 220

Stoudenmire Laura Leigh: Evaluation of obesity on achievingremission following induction therapy for acute myelogenousleukemia 448

Stover Kayla R: Mitochondrial toxicity with caspofungin 130 Strauch Susan: Deeper responses achieved with switch to nilotinib in

patients with Philadelphia-positive chronic myeloid leukemia inchronic phase with suboptimal molecular response to imatinib 183E

Sullivan Peter M: Development of a student pharmacist drivenmedication reconciliation discharge program 437

Sun Shawn: Cost-effectiveness analysis of roflumilast/tiotropiumcombination therapy vs. tiotropium monotherapy in patients withsevere to very severe COPD 250

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Taitel Michael: A community pharmacy, diabetes managementprogram to improve biometric and cardiac risk factors 478

Tallian Kimberly: Impact of a pharmacist on length of stay andreadmission rate at an academic inpatient psychiatric unit 247

Thill Paul: Buprenorphine withdrawal in an infant after cessation ofbreastfeeding: A case report and review of the literature 453

Tichy Eric: A single center experience with conversion between twogeneric tacrolimus formulations 271

Tillman Emma M: Peroxisome proliferator-activated receptor alphaactivity is altered by omega-3 polyunsaturated long-chain fattyacids in a cholestatic liver disease model 206

Todorov Darko: Comparison of aPTT vs. anti-Xa assay for thetherapeutic monitoring of unfractionated heparin 368

Trinkley Katy E: Adverse drug reactions in ambulatory care with anelectronic medical record and electronic prescribing: Identificationand characterization 474

Trivedi Meghana V: Effects of mobilization regimens on the incidenceof tumor cell contamination of the hematopoietic stem cells inbreast cancer patients undergoing peripheral blood stem celltransplantation 445

Trujillo Angelina: Linagliptin effectively reduces HbA1c independentof age in patients with type 2 diabetes 97E

Tsuji Brian T: Vancomycin in combination with naficillindemonstrates synergy against heteroresistant vancomycin-intermediate Staphylococcus aureus (hVISA) 433

Tumlin Holly L: Assessment of recommendations made by a clinicalpharmacist in a palliative care setting: A retrospective cohort study452

Turner Ted J: Determining rates of metabolic monitoring in clozapine-treated outpatients: evaluating the need for a collaborativemetabolic monitoring service 246E

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Ueda Stevenson Kimi: Corticosteroid withdrawal in renal transplantrecipients: an analysis of the mycophenolic acid observational renaltransplant registry 259

Ueda Stevenson Kimi: Early analyses of renal transplant recipientswho received expanded criteria donor kidneys from themycophenolic acid observational renal transplant registry 260

Underwood Julia M: Evaluation of bleeding risk using HAS-BLEDscoring in patients with atrial fibrillation receiving enoxaparinbridging therapy 356

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Vande Griend Joseph P: Targeting testosterone concentrations inelderly males using transdermal testosterone gel 103

Vanguri Amulya: An apparent drug interaction between warfarin andthe antiretroviral TRIO regimen 429

Varenhorst Christoph MH: Cardiac events, infections and bleedscontribute to higher vascular and non-vascular mortality withclopidogrel compared to ticagrelor treatment in patients undergoingcoronary artery bypass grafting 32E

Varnado Sara: Assessing an institution-specific therapeutic


hypothermia protocol: outcomes and associated adverse events 401 Venkataramanan Raman: Progesterone, a female sex hormone, inhibits

CYP3A-mediated metabolism of 17-alpha hydroxyprogesteronecaproate, an agent that prevents preterm birth 242

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Walsh Kelly A: Risk factors for venous thromboembolism in patientswith cirrhosis 9

Watson Kristin: Factors that influence board certification amongpharmacy practice faculty in the US 192

Weitzman Elyse R: Glucose control in cardiac surgery patientsfollowing IV insulin discontinuation 418

Wenger Philip J: Effect of pharmacy team interventions on monitoringrates for second-generation antipsychotics in a correctional setting248

Wesner Amber R: Prospective trial of a novel vancomycin nomogram382

Whaley Sarah G: The Hsp40 co-chaperone Jjj1 is a negative regulatorof fluconazole resistance in Candida glabrata 434

White John R: Dapagliflozin monotherapy and combination therapyreduces hyperglycemia in patients with type 2 diabetes 96E

Whiteside Rachelle: Impact of the propofol shortage on patientoutcomes in a cardiothoracic surgical intensive care unit 50

Whiteside Rachelle: Isotope dilution mass spectrometry influence oncalculating carboplatin doses 380

Wiederhold Nathan P: Influence of serum and albumin onechinocandin pharmacodynamics 144

Willett Kristine C: Improving student desires to advocate for thepharmacy profession after attendance to a state board of pharmacymeeting 63

Wink Crystal J: Results of a pharmacist-managed cardiovascular riskreduction clinic at a Veterans Affairs Medical Center 280

Wolfel Thomas J: A description of antibiotic-related laboratoryinterferences 388

Woodard Susan C: Analysis of pharmacist-driven medicationreconciliation services on hospital readmission rates, emergencyroom, visits, and hospital length of stay 342

Wooding Fae: Evaluating the impact of implementing pharmacycardiology rounds on student exam performance in a

pharmacotherapeutics course 88 Woodis C Brock: Appropriateness of chronic obstructive pulmonary

disease (COPD) management per global initiative for chronicobstructive lung disease (GOLD) guidelines at a family medicinepractice 249

Woodle E Steve: Multivariate analysis of risk factors that influencegraft survival following proteasome inhibitor therapy for antibodymediated rejection 386

Woods J Andrew: An evaluation of inhaled bronchodilator therapy inpatients hospitalized for non-life-threatening COPD exacerbations253E

Woolley Adam B: Evaluation of pharmacy students’ clinicalinterventions and estimated cost avoidance during a generalmedicine rotation 83

Wright Kelly M: Evaluation of a 20-week longitudinal studentprogram 311

Wylie Douglas: Pharmacy student knowledge retention aftercompleting a simulation utilizing high-fidelity mannequinscompared to a written patient case 87

Wytiaz Nicholas P: Identifying optimal dosages of drugs requiringweight-based calculations in over and underweight populations 435

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Yan Shirley: Evaluation of busulfan targeted therapy andpharmacokinetics in pediatric patients undergoing hematopoieticcell transplantation 454

Yep Tracy: The pharmacokinetics of metoprolol during pregnancy 471 Yu Bo: Cut down chemotherapy errors by clinical pharmacist in

Shanghai Cancer Center 340 Yuen Andrea N: Breast cancer patient understanding and knowledge

of pharmacogenomic testing in Lineberger Comprehensive CancerCenter trial 0801 461

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Zhang Xiaoping: Pharmacokinetics and pharmacodynamics oftocilizumab in systemic juvenile idiopathic arthritis 255E

Zillich Alan J: Evaluation of specialized medication packagingcombined with medication therapy management: adherence,outcomes, and costs among Medicaid patients 105

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2011 annual meeting abstracts

Documents